Pediacel Vaccine Detailed Manufacturer Information

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315 PEDIACEL
Section 1.3.1 Product Monograph
PRODUCT MONOGRAPH
PEDIACEL
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Combined with Inactivated Poliomyelitis Vaccine and Haemophilus b Conjugate Vaccine
(Tetanus Protein Conjugate)
Suspension for injection
(For active immunization against Diphtheria, Tetanus, Pertussis, Poliomyelitis and
Haemophilus influenzae Type b Disease)
ATC Code: J07CA06
Sanofi Pasteur Limited

Toronto, Ontario, Canada
Control No.: 151711
Date of Approval: March 2012
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Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION.......................................................5
SUMMARY PRODUCT INFORMATION .............................................................................5
Route of Administration ..........................................................................................................5
Dosage Form/Strength .............................................................................................................5
Clinically Relevant Nonmedicinal Ingredients ........................................................................5
DESCRIPTION...........................................................................................................................5
INDICATIONS AND CLINICAL USE....................................................................................6
Pediatrics .................................................................................................................................6
Geriatrics .................................................................................................................................6
CONTRAINDICATIONS..........................................................................................................6
WARNINGS AND PRECAUTIONS ........................................................................................7
Hematologic .............................................................................................................................8
Immune .................................................................................................................................8
Neurologic................................................................................................................................9
Pregnant Women......................................................................................................................9
Nursing Women .......................................................................................................................9
Pediatrics .................................................................................................................................9
ADVERSE REACTIONS ........................................................................................................10
Clinical Trial Adverse Reactions ...........................................................................................10
Data from Post-Marketing Experience ..................................................................................10
DRUG INTERACTIONS.........................................................................................................12
Vaccine-Drug Interactions .....................................................................................................12
Concomitant Vaccine Administration....................................................................................12
Vaccine-Laboratory Test Interactions....................................................................................12
DOSAGE AND ADMINISTRATION ....................................................................................12
Recommended Dose ..............................................................................................................12
Administration .......................................................................................................................13
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Overdosage ......................................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY.................................................................14
Duration of Effect ..................................................................................................................16
STORAGE AND STABILITY ................................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................16
Dosage Forms ........................................................................................................................16
Composition ...........................................................................................................................16
PART II: SCIENTIFIC INFORMATION.............................................................................18
PHARMACEUTICAL INFORMATION ..............................................................................18
Drug Substance ......................................................................................................................18
Product Characteristics ..........................................................................................................18
CLINICAL TRIALS ................................................................................................................19
Sweden I Efficacy Trial .........................................................................................................21
Sweden II Efficacy Trial ........................................................................................................22
Clinical Trial PB9502 ............................................................................................................23
Immunogenicity .....................................................................................................................23
Safety
...............................................................................................................................27
Clinical Trial PB9602 ............................................................................................................29

Immunogenicity .....................................................................................................................30
Safety
...............................................................................................................................31
Clinical Trial U01-A5I-302 ...................................................................................................33

Immunogenicity .....................................................................................................................33
Safety
...............................................................................................................................33
ADDITIONAL RELEVANT INFORMATION ....................................................................33

REFERENCES .........................................................................................................................36
PART III: CONSUMER INFORMATION ...........................................................................40
ABOUT THIS VACCINE........................................................................................................40
WARNINGS AND PRECAUTIONS ......................................................................................40
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INTERACTIONS WITH THIS VACCINE...........................................................................41

PROPER USE OF THIS VACCINE ......................................................................................41
SIDE EFFECTS AND WHAT TO DO ABOUT THEM ......................................................41
HOW TO STORE IT................................................................................................................41
REPORTING SUSPECTED SIDE EFFECTS ......................................................................42
MORE INFORMATION .........................................................................................................42
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PEDIACEL
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
PART I: HEALTH PROFESSIONAL INFORMATION

SUMMARY PRODUCT INFORMATION
Route of Administration
Intramuscular injection.
Dosage Form/Strength
Suspension for injection.
Each 0.5 mL dose is formulated to contain:
Active Ingredients
Diphtheria toxoid, tetanus toxoid, acellular pertussis [pertussis toxoid (PT), filamentous
haemagglutinin (FHA), pertactin (PRN), fimbriae types 2 and 3 (FIM)], inactivated poliomyelitis
vaccine [type 1 (Mahoney), type 2 (MEF1), type 3 (Saukett)] and purified polyribosylribitol
phosphate capsular polysaccharide (PRP) of Haemophilus influenzae type b covalently bound to
tetanus protein.
Clinically Relevant Nonmedicinal Ingredients
Excipients: aluminum phosphate (adjuvant), 2-phenoxyethanol, polysorbate 80.
Manufacturing process residuals: bovine serum albumin, neomycin, polymyxin B and trace
amounts of streptomycin, formaldehyde and glutaraldehyde.
For a complete listing see DOSAGE FORMS, COMPOSITION AND PACKAGING.
DESCRIPTION
PEDIACEL [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
(Tetanus Protein Conjugate)] is a sterile, uniform, cloudy, white to off-white suspension of
diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed separately on aluminum
phosphate combined with inactivated poliomyelitis vaccine (vero cell origin) types 1, 2 and 3
(IPV), and H. influenzae type b capsular polysaccharide (polyribosylribitol phosphate, PRP)
covalently bound to tetanus protein, and suspended in water for injection. The acellular pertussis
vaccine is composed of 5 purified pertussis antigens (PT, FHA, PRN and FIM).
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INDICATIONS AND CLINICAL USE

PEDIACEL is indicated for primary immunization of infants from the age of 2 months and in
children up to 6 years of age (prior to their 7th birthday) against diphtheria, tetanus, pertussis
(whooping cough), poliomyelitis and invasive H. influenzae type b disease. (See DOSAGE AND
ADMINISTRATION.)
Currently, Haemophilus b conjugate vaccines are not recommended for infants younger than
2 months of age.
According to the National Advisory Committee on Immunization (NACI), children who have had
pertussis, tetanus, diphtheria or H. influenzae type b (Hib) invasive disease should still be
immunized since these clinical infections do not always confer immunity. (1) For persons who
have been exposed to invasive Hib and who are incompletely immunized, refer to the guidelines
in the Canadian Immunization Guide.
NACI recommends that Human Immunodeficiency Virus (HIV)-infected persons, both
asymptomatic and symptomatic, should be immunized against diphtheria, tetanus, pertussis,
poliomyelitis and H. influenzae type b, according to standard schedules. (1)
PEDIACEL is not to be used for the treatment of diseases caused by Corynebacterium
diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus or Haemophilus influenzae type b
infections.
Pediatrics
PEDIACEL is not indicated for persons less than 2 months or to persons 7 years of age or older.
Geriatrics
PEDIACEL is not indicated for use in adult and elderly populations.
CONTRAINDICATIONS
Hypersensitivity
NACI recommends that known systemic hypersensitivity reaction to any component of
PEDIACEL or a life-threatening reaction after previous administration of the vaccine or a
vaccine containing one or more of the same components are contraindications to vaccination. (1)
(2) (3) (See SUMMARY PRODUCT INFORMATION.) Because of uncertainty as to which
component of the vaccine may be responsible, none of the components should be administered.
Alternatively, such persons may be referred to an allergist for evaluation if further immunizations
are considered.
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Acute Neurological Disorders

According to the Advisory Committee on Immunization Practices (ACIP), the following events
are contraindications to administration of any pertussis-containing vaccine, (2) including
PEDIACEL:
Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days
of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable
cause.
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive
encephalopathy. Pertussis vaccine should not be administered to persons with such conditions
until a treatment regimen has been established and the condition has stabilized.
WARNINGS AND PRECAUTIONS
General
Before administration of PEDIACEL, health-care providers should inform the parent or guardian
of the recipient to be immunized of the benefits and risks of immunization, inquire about the
recent health status of the recipient, review the recipients history concerning possible
hypersensitivity to the vaccine or similar vaccine, previous immunization history, the presence of
any contraindications to immunization and comply with any local requirements with respect to
information to be provided to the parent or guardian before immunization and the importance of
completing the immunization series.
It is extremely important that the parent or guardian be questioned concerning any symptoms
and/or signs of an adverse reaction after a previous dose of vaccine. (See
CONTRAINDICATIONS and ADVERSE REACTIONS.)
NACI states that the rates and severity of adverse events in recipients of tetanus toxoid are
influenced by the number of prior doses and level of pre-existing antitoxins. (1) (3)
As with any vaccine, PEDIACEL may not protect 100% of vaccinated individuals.
Vaccines that contain Hib antigen do not provide protection against infections with other types of
H. influenzae, or against meningitis of other origin.
Under no circumstances can the tetanus protein contained in conjugate vaccines containing
tetanus toxoid as protein carrier be used to replace the usual tetanus vaccination.
Sudden infant death syndrome (SIDS) has occurred in infants following administration of DTaP
vaccines. By chance alone, some cases of SIDS can be expected to follow receipt of
PEDIACEL. (4)
Administration Route-Related Precautions: Do not administer PEDIACEL by intravascular
injection; ensure that the needle does not penetrate a blood vessel.
Intradermal or subcutaneous routes of administration are not to be utilized.
PEDIACEL should not be administered into the buttocks.
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Granuloma or sterile abscess at the injection site has been reported with a product containing the
same antigens.
Febrile or Acute Disease: ACIP recommends that vaccination should be postponed in cases of
acute or febrile disease. (2) (3) However, a disease with low-grade fever should not usually be a
reason to postpone vaccination.
If any of the following events occur within the specified period after administration of a wholecell pertussis vaccine or a vaccine containing an acellular pertussis component, the decision to
administer PEDIACEL should be based on careful consideration of potential benefits and
possible risks. (2)
Temperature of 40.5C (105F) within 48 hours, not attributable to another identifiable

cause;
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours;
Persistent crying lasting 3 hours within 48 hours;
Convulsions with or without fever within 3 days.
Hematologic
Because any intramuscular injection can cause an injection site hematoma in persons with any
bleeding disorders, such as hemophilia or thrombocytopenia, or in persons on anticoagulant
therapy, intramuscular injections with PEDIACEL should not be administered to such persons
unless the potential benefits outweigh the risk of administration. If the decision is made to
administer any product by intramuscular injection to such persons, it should be given with
caution, with steps taken to avoid the risk of hematoma formation following injection.
Immune
The possibility of allergic reactions in persons sensitive to components of the vaccine should be
evaluated. Hypersensitivity reactions may occur following the use of PEDIACEL even in
persons with no prior history of hypersensitivity to the product components. Cases of allergic or
anaphylactic reaction have been reported after receiving some preparations containing diphtheria
and tetanus toxoids and/or pertussis antigens. (5)
As recommended by NACI and as with all other products, epinephrine hydrochloride solution
(1:1,000) and other appropriate agents should be available for immediate use in case an
anaphylactic or acute hypersensitivity reaction occurs. (1) Health-care providers should be
familiar with current recommendations for the initial management of anaphylaxis in non-hospital
settings, including proper airway management. (1) For instructions on recognition and treatment
of anaphylactic reactions see the current edition of the Canadian Immunization Guide or visit the
Health Canada website.
According to NACI, immunocompromised persons (whether from disease or treatment) may not
obtain the expected immune response. If possible, consideration should be given to delaying
vaccination until after the completion of any immunosuppressive treatment. (1) Nevertheless,
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vaccination of persons with chronic immunodeficiency such as HIV infection is recommended

even if the antibody response might be limited. (1) (2)
Neurologic
A review by the IOM found evidence for a causal relation between tetanus toxoid and both
brachial neuritis and Guillain-Barr syndrome (GBS). (6) ACIP recommends that if GBS occurred
within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give
PEDIACEL or any vaccine containing tetanus toxoid should be based on careful consideration of
potential benefits and possible risks. (2)
A few cases of demyelinating diseases of the central nervous system, peripheral
mononeuropathies, and cranial mononeuropathies have been reported following vaccines
containing tetanus and/or diphtheria toxoids, although the IOM concluded that the evidence is
inadequate to accept or reject a causal relation between these conditions and vaccination. (6)
ACIP recommends for infants or children at higher risk for seizures than the general population,
an appropriate antipyretic may be administered (in the dosage recommended in its prescribing
information) at the time of vaccination with a vaccine containing an acellular pertussis component
(including PEDIACEL) and for the following 24 hours, to reduce the possibility of postvaccination fever. (2)
Hypotonic-hyporesponsive episodes (HHEs) rarely follow vaccination with whole-cell pertussis
containing DTP vaccines and occur even less commonly after acellular pertussis-containing DTP
vaccines and DT vaccines. The NACI states that a history of HHEs is not a contraindication to the
use of acellular pertussis vaccines but recommends caution in these cases. (1)
Pregnant Women
The vaccine should not be administered to pregnant women.
Nursing Women
The vaccine should not be administered to nursing women.
Pediatrics
The potential risk of apnea and the need for respiratory monitoring for 48 72 hours should be
considered when administering the primary immunization series to very premature infants (born
28 weeks of gestation) and particularly for those with a previous history of respiratory
immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not
be withheld or delayed.
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ADVERSE REACTIONS
Clinical Trial Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates
observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials
of another vaccine and may not reflect rates observed in practice. The adverse reaction
information from clinical trials does, however, provide a basis for identifying the adverse events
that appear to be related to vaccine use and for approximating rates of those events.
In a randomized, controlled clinical trial conducted in Canada, 339 infants were immunized with
PEDIACEL at 2, 4 and 6 months of age. In addition, 301 of these children were immunized as
toddlers at 18 months. (7) Injection site reactions were generally mild. Up to one third of children
receiving PEDIACEL experienced some degree of redness, swelling or tenderness around the
injection site. Solicited injection site reaction rates are shown in Table 1.
Table 1: Frequency (%) of Solicited Reactions Observed Within 24 Hours Following a
Single Dose with PEDIACEL Administered at 2, 4, 6 and 18 Months of Age
2 months
(N = 336)
4 months
(N = 331)
Redness
6.8
12.7
9.7
19.7
Swelling
12.5
10.3
9.7
13.7
Tenderness
22.6
22.1
14.8
33.0
Fever 38.0C
13.4
19.6
15.9
19.5
Crying
27.7
34.7
23.0
17.0
Eating Less
29.2
19.3
15.2
13.3
Diarrhea
9.2
4.8
7.0
7.0
Vomiting
6.8
5.7
3.3
4.0
Fussiness
42.3
46.8
38.2
27.7
Less Active
44.9
29.9
13.9
12.0
Solicited Reactions
6 months
(N = 330)
18 months
(N = 300)
Injection Site Reactions
Systemic Reactions
Data from Post-Marketing Experience

The following additional adverse events have been spontaneously reported during the postmarketing use of PEDIACEL worldwide. Because these events are reported voluntarily from a
population of uncertain size, it is not always possible to reliably estimate their frequency or
establish a causal relationship to vaccine exposure. Decisions to include these events in labelling
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were based on one or more of the following factors: 1) severity of the event, 2) frequency of
reporting, or 3) strength of causal connection to PEDIACEL.
Immune System Disorders
Hypersensitivity, anaphylactic reaction (such as urticaria, angioedema).
Psychiatric Disorders
Irritability, screaming.
Nervous System Disorders
Convulsion (with or without fever), prolonged or unusual high-pitched crying, hypotonic
hyporesponsive episode (infant appears pale, hypotonic [limp] and unresponsive to
parents). To date, this condition has not been associated with any permanent sequelae.
Somnolence.
Vascular Disorders
Pallor.
Respiratory, Thoracic and Mediastinal Disorders
Apnea.
Skin and Subcutaneous Tissue Disorders
Erythema, rash.
Musculoskeletal, Connective Tissue and Bone Disorders
Pain in vaccinated limb.
General Disorders and Administration Site Conditions
High fever (>40.5C), injection site mass, asthenia, and listlessness.
Large injection site reactions (>50 mm) including extensive limb swelling which may
extend from the injection site beyond one or both joints, have been reported in children
following PEDIACEL administration. These reactions usually start within 24 - 72 hours
after vaccination, may be associated with erythema, warmth, tenderness or pain at the
injection site and resolve spontaneously within 3 to 5 days. The risk appears to be
dependent on the number of prior doses of acellular pertussis containing vaccine, with a
greater risk following the 4th and 5th doses.
Edematous reactions affecting one or both lower limbs have occurred following
vaccination with H. influenza type b containing vaccines. When this reaction occurs, it
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does so mainly after primary injections and is observed within the first few hours
following vaccination. Associated symptoms may include cyanosis, redness, transient
purpura and severe crying. All events resolved spontaneously without sequelae within 24
hours.
Physicians, nurses and pharmacists should report any adverse occurrences temporally related to
the administration of the product in accordance with local requirements and to the Global
Pharmacovigilance Department, Sanofi Pasteur Limited, 1755 Steeles Avenue West, Toronto,
ON, M2R 3T4 Canada. 1-888-621-1146 (phone) or 416-667-2435 (fax).
DRUG INTERACTIONS
Vaccine-Drug Interactions
Immunosuppressive treatments may interfere with the development of the expected immune
response. (See WARNINGS AND PRECAUTIONS.)
Concomitant Vaccine Administration
NACI states that administering the most widely used live and inactivated vaccines during the
same patient visit has produced seroconversion rates and rates of adverse reactions similar to
those observed when the vaccines are administered separately. (1) NACI recommends that
vaccines administered simultaneously should be given using separate syringes at separate sites.
(1) (2) Simultaneous administration is suggested, particularly when there is concern that a person
may not return for subsequent vaccination.
PEDIACEL should not be mixed in the same syringe with other parenterals.
Vaccine-Laboratory Test Interactions
Antigenuria has been detected in some instances following administration of a vaccine containing
Hib antigen. Therefore, urine antigen detection may not have definite diagnostic value in
suspected H. influenzae type b disease within two weeks of immunization. (8)
DOSAGE AND ADMINISTRATION
Recommended Dose
For routine immunization, PEDIACEL is recommended as a 4-dose series, with a single dose of
0.5 mL of PEDIACEL at 2, 4, 6 and 18 months of age.
If for any reason this schedule is delayed, it is recommended that 3 doses be administered with an
interval of 2 months between each dose followed by a fourth dose approximately 6 to 12 months
after the third dose.
Whenever feasible, PEDIACEL should be used for all 4 doses in the vaccination series as there
are no clinical data to support the use of PEDIACEL with any other licensed acellular pertussis
combination vaccine in a mixed sequence. For situations where a different brand of DTaP or
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DTaP-IPV or DTaP-IPV/Hib vaccine was originally used, or where the brand is unknown, please
refer to the latest edition of the Canadian Immunization Guide.
NACI recommends that premature infants whose clinical condition is satisfactory should be
immunized with full doses of vaccine at the same chronological age and according to the same
schedule as full-term infants, regardless of birth weight. (1)
Fractional doses (doses <0.5 mL) should not be given. The effect of fractional doses on the safety
and efficacy has not been determined.
In compliance with NACIs recommended immunization schedule, the childhood immunization
series should be completed with a single 0.5 mL dose of Sanofi Pasteur Limiteds
QUADRACEL [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Combined with Inactivated Poliomyelitis Vaccine] between 4 and 6 years of age (i.e., at the time
of school entry). Alternatively, ADACEL [Tetanus Toxoid, Reduced Diphtheria Toxoid and
Acellular Pertussis Vaccine Adsorbed] and IPV may be administered at separate sites for this
booster at 4 to 6 years of age. This booster dose is unnecessary if the fourth dose of PEDIACEL
was administered after the childs fourth birthday. (1)
A subsequent booster should be administered 10 years later, during adolescence with ADACEL
or Td Adsorbed. Thereafter, routine booster immunizations should be with Td at intervals of 10
years.
PEDIACEL should not be administered to persons less than 2 months or to persons 7 years of
age or older. (See INDICATIONS AND CLINICAL USE.)
Administration
Inspect for extraneous particulate matter and/or discolouration before use. If these conditions
exist, the product should not be administered.
Shake the vial well until a uniform, cloudy, suspension results. Cleanse the vial stopper with a
suitable germicide prior to withdrawing the dose. Do not remove either the stopper or the metal
seal holding it in place.
Aseptic technique must be used. Use a separate, sterile syringe and needle, or a sterile disposable
unit, for each individual patient to prevent disease transmission. Needles should not be recapped
but should be disposed of according to biohazard waste guidelines.
Before injection, the skin over the site to be injected should be cleansed with a suitable germicide.
Administer the total volume of 0.5 mL intramuscularly (I.M.). In infants younger than 1 year,
the anterolateral aspect of the thigh provides the largest muscle and is the preferred site of
injection. In older children, the deltoid muscle is usually large enough for injection.
Give the patient a permanent personal immunization record. In addition, it is essential that the
physician or nurse record the immunization history in the permanent medical record of each
patient. This permanent office record should contain the name of the vaccine, date given, dose,
manufacturer and lot number.
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Overdosage
For management of a suspected drug overdose, contact your regional Poison Control Centre.
ACTION AND CLINICAL PHARMACOLOGY
Diphtheria and Tetanus: Strains of C. diphtheriae that produce diphtheria toxin can cause
severe or fatal illness characterized by membranous inflammation of the upper respiratory tract
and toxin-induced damage to the myocardium and nervous system. Protection against disease
attributable to C. diphtheriae is due to the development of neutralizing antibodies to diphtheria
toxin. ACIP states that a serum diphtheria antitoxin level of 0.01 IU/mL is considered the lowest
level giving some degree of protection. Antitoxin levels of at least 0.1 IU/mL are generally
regarded as protective. (2) (3) Levels of 1.0 IU/mL have been associated with long-term
protection. (3)
Tetanus is an acute and often fatal disease caused by an extremely potent neurotoxin produced by
C. tetani. The toxin causes neuromuscular dysfunction, with rigidity and spasms of skeletal
muscles. Protection against disease attributable to C. tetani is due to the development of
neutralizing antibodies to tetanus toxin. ACIP states that a serum tetanus antitoxin level of at least
0.01 IU/mL, measured by neutralization assay, is considered the minimum protective level. (2) (3)
A tetanus antitoxin level of at least 0.1 IU/mL as measured by the ELISA used in clinical studies
of PEDIACEL is considered protective for tetanus. Levels of 1.0 IU/mL have been associated
with long-term protection.
In a clinical trial in Canada, after 4 doses of PEDIACEL, 100% (N = 300) of immunized
children achieved serum diphtheria and tetanus antitoxin levels of at least 0.01 IU/mL and 100%
of these children achieved serum antitoxin levels of at least 0.1 IU/mL for diphtheria and tetanus.
After completion of the childhood immunization series, circulating antibodies to diphtheria and
tetanus toxoids gradually decline but are thought to persist at protective levels for up to 10 years.
NACI recommends diphtheria and tetanus toxoids boosters every 10 years. (1)
Pertussis: Pertussis (whooping cough) is a respiratory disease caused by B. pertussis. This Gramnegative coccobacillus produces a variety of biologically active components, though their role in
either the pathogenesis of, or immunity to, pertussis has not been clearly defined. The mechanism
of protection from B. pertussis disease is not well understood. However, in a clinical trial in
Sweden (Sweden I Efficacy Trial), pertussis components in PEDIACEL (i.e., PT, FHA, PRN
and FIM) have been shown to prevent pertussis in infants with a protective efficacy of 85.2%
using the World Health Organization (WHO) case definition (21 consecutive days of
paroxysmal cough with culture or serologic confirmation or epidemiological link to a confirmed
case). In the same study, the protective efficacy against mild disease was 77.9%.
Minimum serum antibody levels to specific pertussis vaccine components that confer protection
against the development of clinical pertussis have not been identified. Nevertheless, a number of
studies have demonstrated a correlation between the presence of serum antibody responses to
pertussis vaccine components and protection against clinical disease. (9) (10) (11) (12) (13) (14)
In a controlled clinical trial in Sweden (Sweden II Trial), the efficacy of a DTaP vaccine with the
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same formulation in pertussis antigens as PEDIACEL was demonstrated to provide a two-fold to

three-fold higher protection against pertussis with any cough compared to the three pertussis
antigens vaccine. The observed difference supports the role of fimbriae types 2 and 3 in the
protection against colonization of B. pertussis and mild disease.
PEDIACEL is a fully liquid version of PENTACEL [Haemophilus b Conjugate Vaccine
(Tetanus Protein Conjugate) Reconstituted with Diphtheria and Tetanus Toxoids and Acellular
Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine] with both
vaccines containing similar antigens. PENTACEL has been used in the prevention and control of
pertussis in Canada since it was introduced in 1997 1998. Over 13 million doses of
PENTACEL have been administered to Canadian children (at 2, 4, 6 and 18 months of age)
since 1997.
In a recent publication, Bettinger et al reviewed pertussis cases during 1991-2004 using
surveillance data from the Canadian Immunization Monitoring Program, Active (IMPACT), an
active surveillance network based in 12 pediatric tertiary-care hospitals across Canada. (15)
Overall, the data show declining rates of pertussis during the years in which PENTACEL has
been used (1999-2004) compared to the period when whole-cell pertussis vaccine was used
(1991-1996). Among children 1-4 years of age, incidence of pertussis declined 85%. Data from
the Northwest Territories, (16) Newfoundland and Labrador (17) and British Columbia (18)
support national and IMPACT data demonstrating a progressive decline of pertussis cases among
infants and children through 9 years of age.
Poliomyelitis: Inactivated poliomyelitis vaccine induces the production of detectable levels of
neutralizing antibodies against each type of poliovirus. The detection of type-specific neutralizing
antibodies has been correlated with protection. (19) A clinical study of PEDIACEL in 300
Canadian infants showed that, after 4 doses, more than 99.7% of vaccinated children achieved
protective antibody levels (titres 1:8) to poliovirus types 1, 2 and 3 following the primary series.
(7)
Haemophilus influenzae Type b: The response to a Haemophilus b conjugate vaccine is typical
of a T-dependent immune response with induction of immunological priming and memory. (3)
Bactericidal activity against Hib is demonstrated in serum after immunization and correlates with
the anti-PRP antibody response induced by Hib conjugate vaccine. In children aged 24 months,
antibody titres to H. influenzae capsular polysaccharide (anti-PRP) of 0.15 g/mL following
vaccination with unconjugated PRP vaccine correlated with protection against invasive
H. influenzae type b disease immediately after immunization, whereas titres 1.0 g/mL
correlated with protection for at least 1 year. (20) Although the relevance of the 0.15 g/mL and
1.0 g/mL thresholds to clinical protection after immunization with conjugate vaccines is not
known, these levels have been used to gauge antibody response to vaccination. In a clinical study
of PEDIACEL in 300 infants in Canada after 4 doses, 100% of vaccinated children achieved
protective antibody titres 0.15 g/mL, and 99.0% achieved protective antibody levels
1.0 g/mL. (7)
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315 PEDIACEL
Duration of Effect
To ensure optimal protection during childhood, 4 consecutive doses should be given at 2, 4, 6 and
18 months of age. A booster with a vaccine containing diphtheria, tetanus, acellular pertussis with
or without IPV is required at 4 to 6 years.
STORAGE AND STABILITY
Store at 2 to 8C (35 to 46F). Do not freeze. Discard product if exposed to freezing ( 0C).
PEDIACEL has been shown to remain stable at temperatures above 8C and up to 25C, for a
maximum of 3 days (72 hours). These data are not recommendations for shipping or storage, but
may guide decision for use in case of temporary temperature excursions.
Do not use after expiration date.
DOSAGE FORMS, COMPOSITION AND PACKAGING
Dosage Forms
PEDIACEL is supplied as a sterile, uniform, cloudy, white to off-white suspension in a vial.
Composition
Each single dose (0.5 mL) contains:
Active Ingredients
Diphtheria Toxoid
15 Lf
Tetanus Toxoid
5 Lf
Acellular Pertussis
Pertussis Toxoid (PT)
20 g
Filamentous Haemagglutinin (FHA)
20 g
Pertactin (PRN)
3 g
Fimbriae Types 2 and 3 (FIM)
5 g
Inactivated Poliomyelitis Vaccine
Type 1 (Mahoney)
40 D-antigen units*
Type 2 (MEF1)
8 D-antigen units*
Type 3 (Saukett)
32 D-antigen units*
Purified Polyribosylribitol Phosphate Capsular
Polysaccharide (PRP) of Haemophilus influenzae
Type b covalently bound to 18-30 g of Tetanus Protein 10 g
* or the equivalent antigen quantity, determined by suitable immunochemical method
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315 PEDIACEL
Other Ingredients
Excipients
Aluminum Phosphate (adjuvant)
2-phenoxyethanol
Polysorbate 80
1.5 mg
0.6% v/v
0.1% w/v (by calculation)
Manufacturing Process Residuals

Bovine serum albumin, neomycin, polymyxin B, streptomycin, formaldehyde and glutaraldehyde
are present in trace amounts.
Packaging
PEDIACEL is supplied in single dose vials.
The vials are made of Type 1 glass. The container closure system of PEDIACEL does not
contain latex (natural rubber).
PEDIACEL is available in a package of:
1 single dose (0.5 mL) vial
5 single dose (0.5 mL) vials
Vaccine Information Service: 1-888-621-1146 or 416-667-2779. Business Hours: 8 a.m. to 5 p.m.
Eastern Time Monday to Friday.
Full product monograph available on request or visit us at www.sanofipasteur.ca
Product information as of February 2012.
Manufactured by:
R11-0212 Canada
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315 PEDIACEL
PART II: SCIENTIFIC INFORMATION

PHARMACEUTICAL INFORMATION
Drug Substance
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Combined with Inactivated Poliomyelitis Vaccine and Haemophilus b Conjugate
Vaccine (Tetanus Protein Conjugate)
Product Characteristics
PEDIACEL is a sterile, uniform, cloudy, white to off-white suspension of diphtheria and tetanus
toxoids adsorbed on aluminum phosphate and acellular pertussis vaccine combined with
inactivated poliomyelitis vaccine (vero cell origin) types 1, 2 and 3 and H. influenzae type b
capsular polysaccharide (polyribosylribitol phosphate, PRP) covalently bound to tetanus protein,
and suspended in water for injection. The acellular pertussis vaccine is composed of 5 purified
pertussis antigens (PT, FHA, PRN and FIM).
C. diphtheriae is grown in modified Muellers growth medium. (21) After purification by
ammonium sulphate fractionation, the diphtheria toxin is detoxified with formaldehyde and
diafiltered. C. tetani is grown in modified Mueller-Miller casamino acid medium without beef
heart infusion. (22) Tetanus toxin is detoxified with formaldehyde and purified by ammonium
sulphate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed
onto aluminum phosphate.
The 5 acellular pertussis vaccine components are produced from B. pertussis cultures grown in
Stainer-Scholte medium (23) modified by the addition of casamino acids and dimethyl-betacyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. The
FIM components are extracted and co-purified from the bacterial cells. The pertussis antigens are
purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is
detoxified with glutaraldehyde and FHA is treated with formaldehyde. The residual aldehydes are
removed by diafiltration. The individual antigens are adsorbed separately onto aluminum
phosphate.
The adsorbed diphtheria, tetanus and acellular pertussis components are combined into an
intermediate concentrate.
Inactivated poliomyelitis vaccine (IPV) is a highly purified, inactivated poliovirus vaccine
including three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1) and Type 3 (Saukett).
Each of the three strains of poliovirus is individually grown in vero cells cultivated on
microcarriers. The single virus harvest is concentrated and purified, then inactivated with
formaldehyde to produce the type 1, 2 or 3 monovalent. Monovalents of each type are then
combined in appropriate quantities to produce a trivalent concentrate.
The Haemophilus b conjugate (Hib) component of PEDIACEL consists of the Haemophilus b
capsular polysaccharide (polyribosylribitol phosphate, PRP), a high molecular weight polymer
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315 PEDIACEL
prepared from the H. influenzae type b strain 1482 grown in a semi-synthetic medium, covalently
bound to tetanus protein. (24) The tetanus protein is prepared by ammonium sulphate purification,
and formalin inactivation of the toxin from cultures of C. tetani (Harvard strain) grown in a
modified Mueller and Miller medium. (25) The protein is filter sterilized prior to the conjugation
process.
The adsorbed diphtheria, tetanus and acellular pertussis components intermediate concentrate is
combined with concentrates of PRP-T conjugate and IPV (vero types 1, 2 and 3). Water for
injection containing polysorbate 80 and 2-phenoxyethanol are added to make the final
formulation.
Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL in the guinea pig
potency test. The potency of the acellular pertussis vaccine components is evaluated by the
antibody response of immunized guinea pigs to PT, FHA, PRN and FIM as measured by enzymelinked immunosorbent assay (ELISA). The antigenicity of the IPV is evaluated by the antibody
response in rats measured by virus neutralization. Potency of PRP-T is specified on each lot by
limits on the content of PRP polysaccharide in each dose and the proportion of free
polysaccharide.
CLINICAL TRIALS
Four pivotal clinical trials (Sweden Trial I, Sweden Trial II, PB9502 and PB9602) conducted in
Sweden and in Canada provide the clinical basis for the licensure of PEDIACEL in Canada. (See
Table 2.)
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315 PEDIACEL
Table 2: Summary of Demographics and Study Design of the Trials with PEDIACEL
Study
Study Design
Sweden I
(7)
Randomized, placebocontrolled, double-blind,

efficacy and safety trial with
one whole cell DTP, two
DTaP vaccines (2 and 5component).
Sweden II
(7) (26)
Randomized, controlled,
double-blind, multicentre
efficacy trial with one whole
cell DTP and three DTaP
vaccines (2, 3 and 5component).
PB9502 (7)
single-blinded multicentre
safety and immunogenicity
comparative trial with
PEDIACEL,
PENTACEL, PENTA
and QUADRACEL,
Act-HIB**.
PB9602 (7)
single-blinded, multicentre
safety and immunogenicity
comparative trial with
PEDIACEL and PENTA.
U01-A5I302 (7)
open, multicentre safety and
immunogenicity trial of
PEDIACEL Compared to
(Act-HIB /DTP and OPV),
Each Co-Administered with
NeisVac-C or Menjugate
Dosage and
Route of
Administration
Vaccination Schedule/
Study Population*
0.5 mL I.M.
2, 4, 6 months of age
N = 2,587
0.5 mL I.M.
N = 2,551
and
N = 18,196
0.5 mL I.M.
2, 4, 6 and
18 months of age
N = 339
0.5 mL I.M.
0.5 mL I.M.
2, 4, 6 and
18 months of age
Gender
Males
N = 1,330
Females
N = 1,257
Males
N = 10,590
Females
N = 10,157
Males
N = 183
Females
N = 156
Males
N = 65
N = 112
Females
N = 47
2, 3, and 4 months of
age
Males
N = 128
N= 241
Females
N = 113
Number enrolled.
PENTACEL [Haemophilus b Conjugate Vaccine (Tetanus Protein Conjugate) Reconstituted with Diphtheria
and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis
Vaccine].
PENTA is a whole-cell DPT-Polio (MRC-5) with lyophilized PRP-T vaccine.
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315 PEDIACEL
QUADRACEL [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with
Inactivated Poliomyelitis Vaccine]
** Act-HIB [Haemophilus b Conjugate Vaccine (Tetanus Protein Conjugate)].
Sweden I Efficacy Trial

A randomized, double-blinded, placebo-controlled efficacy and safety study was conducted in
Sweden from 1992 - 1995 (Sweden I Efficacy Trial) under the sponsorship of the National
Institute of Allergy and Infectious Diseases (NIAID). (26) A total of 9,829 infants received 1 of 4
vaccines: TRIPACEL [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine
Adsorbed], the five-component DTaP vaccine that contains the same antigens present in
PEDIACEL (N = 2,587); a two-component DTaP vaccine (N = 2,566); a whole-cell pertussis
DTP vaccine from the U.S. (N = 2,102); or DT vaccine (Swedish National Bacteriological
Laboratory) as placebo (N = 2,574). Infants were immunized at 2, 4 and 6 months of age. The
mean length of follow-up was 2 years after the third dose of vaccine. The protective efficacy of
TRIPACEL against pertussis after 3 doses of vaccine using the World Health Organization
(WHO) case definition (21 consecutive days of paroxysmal cough with culture or serologic
confirmation or epidemiologic link to a confirmed case) was 85.2% (95% confidence interval [CI]
80.6 to 88.8). (26) The protective efficacy of TRIPACEL against mild pertussis (1 day of
cough with laboratory confirmation) was 77.9% (95% CI 72.6 to 82.2). Protection against
pertussis by TRIPACEL was sustained for the 2-year follow-up period. (26) (See Table 3.)
Table 3: Vaccine Efficacy Against Pertussis Infection of Varying Clinical Severity (7) (26)
Clinical Severity of Pertussis
Vaccine Efficacy (%) of TRIPACEL (N = 2,551)

Compared to DT Control (N = 2,539)
cough 1 day
77.9
cough >7 days
78.4
cough 21 days
81.4
cough 30 days
87.3
paroxysmal cough 14 days
82.3
paroxysmal cough 21 days
85.1
Another arm of the trial (7) (26) looked at the persistence of the protection provided by this
TRIPACEL formulation compared to a placebo. High levels of protection were sustained for
TRIPACEL over the entire 2-year follow-up period.
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315 PEDIACEL
Table 4: Duration of Vaccine Efficacy for TRIPACEL Compared to Placebo (7) (26)
Vaccine Efficacy (%) Compared to DT (Placebo N = 2,068)
Interval Since Third Dose
(in days)
0-89
TRIPACEL (N = 2,069)
95
90-179
83.6
180-269
86.7
270-359
84.4
360-449
92.1
450-539
78.3
540-629
86.4
630-719
81.3
The incidence of injection site and systemic reactions after administration of TRIPACEL was
comparable to the DT control group. (7) (26)
A sub-study of this trial looked specifically at immunized children exposed to pertussis from other
members of their households. (9) This formulation of TRIPACEL was more efficacious than any
of the other acellular and whole-cell vaccines studied. There was a correlation between clinical
protection and the presence of anti-PRN, anti-FIM and anti-PT antibodies respectively in the
serum of immunized children.
Sweden II Efficacy Trial
A second NIAID-sponsored, prospective, randomized, double-blinded efficacy trial was
conducted in Sweden (Sweden II Efficacy Trial) from 1993 to 1996. Infants (N = 82,892) were
randomized to receive one of four vaccines: a two-component acellular DTaP vaccine
(N = 20,697); a three-component acellular DTaP vaccine (N = 20,728); the same formulation of
the five-component acellular DTaP vaccine that is contained in PEDIACEL (N = 20,747); or a
European whole-cell DTP vaccine (N = 20,720). (27) Vaccination occurred at 3, 5 and 12 months
of age (88% of participants) or at 2, 4 and 6 months of age (12% of participants). The relative risk
of typical pertussis (culture-confirmed B. pertussis infection with at least 21 days of paroxysmal
cough) was 0.85 and 1.38 among children given the five-component and three-component
vaccines, respectively, as compared with those given the whole-cell vaccine. The relative risk of
typical pertussis was 0.62 among children given the five-component vaccine as compared with the
three-component vaccine. The absolute efficacy of the three-component vaccine, when tested in
an earlier double-blinded randomized placebo-controlled trial in Italy was 84% (95% CI, 76-89).
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315 PEDIACEL
(28) Although the absolute efficacy of the five-component vaccine could not be determined in the
Sweden II Efficacy Trial because of the lack of a DT control group, based on the relative risk
data, it appears that the five-component vaccine demonstrated improved efficacy compared with
the 84% absolute efficacy associated with the three-component vaccine. The observed difference
supports the role of fimbriae types 2 and 3 (FIM) in the protection against colonization by
B. pertussis and mild disease. (27)
Table 5: Geometric Mean Titres (GMTs) to Pertussis Antigens Following the Third Dose
(Vaccine Administered at 2, 4 and 6 Months)
Pertussis Antigens
TRIPACEL (N = 80)
GMT (EU/mL)
PT
51.6
FHA
57.0
PRN
134.4
FIM
351.9
Rates of serious adverse events were less than or comparable to the rates in the other acellular
pertussis and European whole-cell DTP groups in this study. (7) (27)
Clinical Trial PB9502
In a randomized controlled clinical trial conducted in Canada between 1995 and 1997, 787 infants
received PEDIACEL (N = 339), PENTACEL (N = 335), PENTA (N = 112), or
QUADRACEL and Act-HIB, given concomitantly at separate sites (N = 113) at 2, 4, and 6
months of age. Of the 787 children enrolled, 708 received a fourth dose of the same vaccine at 1820 months of age.
Immunogenicity
In study PB9502 the immunogenicity of PEDIACEL was found to be similar to that for
PENTACEL. One month after the third and fourth doses, no clinically significant differences
were observed between the antibody responses to each of the vaccine antigens in children
receiving PEDIACEL and those receiving PENTACEL. (See Table 3 through Table 7.) After
the third and fourth doses, at least 97.9% of the PEDIACEL vaccinees achieved seroprotective
levels against Hib disease (anti-PRP antibody 0.15 g/mL), diphtheria (diphtheria antitoxin
0.01 IU/mL), tetanus (tetanus antitoxin 0.01 EU/mL) and poliomyelitis types 1, 2, and 3
(poliovirus neutralizing antibody titre 1:8). (See Table 6 and Table 7.) Seroconversion rates
(% 4-fold rise) were high for each of the pertussis antibodies after the primary series. (See Table
8.) A robust booster response was observed after the fourth dose. (7) (See Table 7 and Table 9.)
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Table 6: Antibody Responses to PRP-T, Diphtheria and Tetanus Toxoids and Poliovirus
Types 1, 2 and 3 Measured One Month After the Third Dose of the Primary Series with
PEDIACEL or PENTACEL in Clinical Trial PB9502 (7)
Post 3rd Dose (7 months of age)
PEDIACEL
(N = 324)
PENTACEL
(N = 321)
4.86
4.40
(4.21, 5.62)
(3.78, 5.13)
% 0.15 g/mL
97.9
98.5
% 1.0 g/mL
88.9
84.7
GMC
0.29
0.28
(0.25, 0.33)
(0.24, 0.33)
% 0.01 IU/mL
100.0
98.4
% 0.10 IU/mL
78.7
76.7
GMC
1.09
0.88
(1.00, 1.20)
(0.80, 0.96)
% 0.01 EU/mL
100.0
100.0
% 0.10 EU/mL
99.7
99.1
GMT
616
723
(526, 723)
(593, 882)
% 1:8
100.0
99.4
GMT
2,382
2,178
(2,026, 2,800)
(1,841, 2,578)
% 1:8
99.7
100.0
GMT
1,266
1,942
(1,079, 1,485)
(1,642, 2,297)
99.7
99.4
Antibody
Result
GMC
Anti-PRP
Diphtheria
Tetanus
Polio Type 1
Polio Type 2
Polio Type 3
(95% CI)
(95% CI)
(95% CI)
(95% CI)
(95% CI)
(95% CI)
% 1:8
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315 PEDIACEL
Types 1, 2 and 3 Measured Immediately Before and One Month After a Fourth Dose at 18
to 19 Months of Age with PEDIACEL or PENTACEL in Clinical Trial PB9502 (7)
Pre 4th Dose
Antibody
Result
PEDIACEL
(N = 300)
PENTACEL
(N = 294)
PEDIACEL
(N = 300)
PENTACEL
(N = 294)
0.55
0.42
32.3
30.1
(0.48, 0.64)
(0.35, 0.49)
(28.4, 36.8)
(26.4, 34.2)
% 0.15 g/mL
85.2
75.4
100.0
100.0
% 1.0 g/mL
24.8
25.3
99.0
99.0
GMC
0.05
0.05
4.13
4.42
(0.04, 0.06)
(0.04, 0.06)
(3.58, 4.76)
(3.82, 5.11)
% 0.01 IU/mL
92.0
89.5
100.0
100.0
% 0.10 IU/mL
27.2
25.5
100.0
99.7
GMC
0.53
0.40
10.1
7.52
(0.48, 0.59)
(0.35, 0.45)
(9.33, 11.0)
(6.89, 8.21)
% 0.01 EU/mL
99.3
99.3
100.0
100.0
% 0.10 EU/mL
96.7
90.8
100.0
100.0
GMT
115
108
7,804
14,874
(96.7, 137)
(88.3, 133)
(6,649, 9,160)
(12,303, 17,983)
% 1:8
92.7
90.8
99.7
99.7
GMT
310
303
17,560
21,690
(256, 377)
(253, 364)
(15,052, 20,486)
(18,711, 25,145)
% 1:8
97.0
98.3
100.0
100.0
GMT
141
243
12,417
22,931
(115, 172)
(197, 300)
(10,305, 14,962)
(19,207, 27,376)
91.7
94.9
100.0
100.0
GMC
Anti-PRP
Diphtheria
Tetanus
Polio Type 1
Polio Type 2
Polio Type 3
Post 4th Dose
(95% CI)
(95% CI)
(95% CI)
(95% CI)
(95% CI)
(95% CI)
% 1:8
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315 PEDIACEL
Table 8: Pertussis Antibody Responses Measured One Month After the Third Dose of the
Primary Series with PEDIACEL or PENTACEL in Clinical Trial PB9502 (7)
Post 3rd Dose (7 months of age)
Antibody
Result
PEDIACEL
N = 324
PENTACEL
N = 321
86.7
89.0
(80.8, 93.0)
(82.5, 96.0)
% 4-fold rise*
92.5
92.2
GMC (EU/mL)
155.0
152.6
(146.5, 164.1)
(143.7, 162.2)
% 4-fold rise*
86.0
87.1
GMC (EU/mL)
55.4
55.9
(48.8, 62.8)
(49.3, 63.3)
% 4-fold rise*
85.5
85.2
GMC (EU/mL)
277.2
243.8
(242.7, 316.5)
(210.8, 282.1)
85.4
84.7
GMC (EU/mL)
PT
FHA
PRN
FIM
(95% CI)
(95% CI)
(95% CI)
(95% CI)
% 4-fold rise*
Percentage of vaccinees attaining at least a 4-fold increase over their pre-immunization antibody level at 2
months of age.
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Table 9: Pertussis Antibody Responses Measured Immediately Before and One Month After
a Fourth Dose with PEDIACEL or PENTACEL in Clinical Trial PB9502 (7)
4th Dose (18 to 19 months of age)
Antibody
Result
FHA
PRN
FIM
PEDIACEL
(N = 324)
PENTACEL
(N = 321)
Post-Immunization
PEDIACEL
(N = 300)
PENTACEL
(N = 294)
11.9
11.4
222
182
(10.8, 13.0)
(10.3, 12.7)
(204, 241)
(166, 199)
% 4-fold rise*
98.6
96.8
GMC (EU/mL)
19.9
20.9
266
245
(18.1, 21.9)
(18.7, 23.2)
(248, 285)
(228, 263)
% 4-fold rise
93.8
91.0
GMC (EU/mL)
9.3
9.6
208
210
(8.2, 10.6)
(8.4, 10.9)
(184, 235)
(185, 239)
% 4-fold rise
98.3
97.8
GMC (EU/mL)
38.4
37.9
842
855
(33.4, 44.3)
(32.7, 44.0)
(748, 948)
(753, 971)
94.1
95.7
GMC (EU/mL)
PT
Pre-Immunization
(95% CI)
(95% CI)
(95% CI)
(95% CI)
% 4-fold rise
* Percentage of vaccinees attaining at least a 4-fold increase over their pre-immunization antibody level at 18 to 19
months of age.
Safety
Solicited injection site reactions occurred in 6.8% (redness) to 33.0% (tenderness) of
PEDIACEL vaccinees. Severe injection site reactions were observed in only 0.6% (tenderness)
to 5.0% (redness). (See Table 8.) The frequency of reactions at the injection site was generally
higher after the fourth dose than in the previous three doses in infants, however, severe tenderness
did not increase with the fourth dose. Systemic reactions occurred in 3.3% (vomiting) to 46.8%
(fussiness). Except for fussiness after the fourth dose (2.0%), severe systemic reactions were
uncommon. (See Table 8.) No child immunized with PEDIACEL experienced a fever 40C.
The adverse event profile of PEDIACEL was comparable to that observed with PENTACEL.
(See Table 11.)
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315 PEDIACEL
Single Dose with PEDIACEL Administered at 2, 4, 6 and 18 Months of Age in Clinical
Trial PB9502 (7)
2 months
(N = 336)
4 months
(N = 331)
6 months
(N = 330)
18 months
(N = 300)
27.7
34.7
23.0
17.0
0.3
44.9
29.9
13.9
12.0
0.9
29.2
19.3
15.2
13.3
Severe
0.3
Any
9.2
4.8
7.0
7.0
Severe
0.3
13.4
19.6
15.9
19.5
42.3
46.8
38.2
27.7
Severe**
0.9
0.6
0.3
1.7
Injection Site
Redness
Any
6.8
12.7
9.7
19.7
35 mm
1.2
0.9
1.2
5.3
Injection Site
Swelling
Any
12.5
10.3
9.7
13.7
5.1
3.6
3.3
4.0
Injection Site
Tenderness
Any
22.6
22.1
14.8
33.0
Severe
0.6
2.4
1.8
1.7
Any
6.8
5.7
3.3
4.0
Severe
Solicited Reaction
Crying
Less Active
Eating Less
Diarrhea
Fever
Fussiness
Vomiting
**
Any
Severe*
Any
Severe
Any
Any
40C
Any
35 mm
Cried continuously for 3 hrs.

Sleeping most of the time.
Refused most or all feeds.
Multiple liquid stools without any solid consistency.
Continuously fussy for 3 hrs.
Baby cries when leg is moved.
Frequent vomiting and inability to have any oral intake.
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315 PEDIACEL
Table 11: Frequency (%) of Solicited Reactions Observed Within 24 Hours Following the
Administration of PEDIACEL or PENTACEL at 2, 4, 6 and 18 Months of Age in Clinical
Trial PB9502 (7)
Age (months)
Vaccine
Solicited Reaction
PEDIACEL
PENTACEL
Crying
Less Active
Eating Less
Diarrhea
Fever
Fussiness
Injection Site
Redness
Injection Site
Swelling
Injection Site
Tenderness
Vomiting
PEDIACEL
PENTACEL
PEDIACEL
PENTACEL
PEDIACEL
PENTACEL
PEDIACEL
PENTACEL
PEDIACEL
PENTACEL
PEDIACEL
PENTACEL
PEDIACEL
PENTACEL
PEDIACEL
PENTACEL
PEDIACEL
PENTACEL
PEDIACEL
PENTACEL
18
N = 336
N = 331
N = 330
N = 300
N = 333
N = 327
N = 320
N = 295
27.7
34.7
23.0
17.0
30.6
41.5
27.6
18.6
44.9
29.9
13.9
12.0
46.8
30.8
20.7
9.8
29.2
19.3
15.2
13.3
27.6
20.7
15.4
17.0
9.2
4.8
7.0
7.0
10.2
7.6
6.6
5.4
13.4
19.6
15.9
19.5
18.6
19.5
15.0
21.5
42.3
46.8
38.2
27.7
43.5
53.4
37.0
30.2
6.8
12.7
9.7
19.7
8.7
11.9
11.6
19.3
12.5
10.3
9.7
13.7
11.7
8.8
9.4
14.2
22.6
22.1
14.8
33.0
26.4
27.1
19.7
28.1
6.8
5.7
3.3
4.0
8.7
5.2
4.7
4.4
Clinical Trial PB9602

Additional safety and immunogenicity data were obtained from a randomized controlled clinical
trial conducted in Canada during 1996 - 1998. This study involved 566 infants who were enrolled
to receive one lot of PEDIACEL (N = 112), one lot of PENTA (N = 113) or one of three lots
(N = 341) of a formulation of PEDIACEL containing reduced amounts of PT (10 g) and FHA
(5 g), at 2, 4, 6 and 18 months of age.
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315 PEDIACEL
Immunogenicity
After the third and fourth doses, at least 97.2% of the PEDIACEL vaccinees achieved
seroprotective levels against Hib disease (anti-PRP antibody 0.15 g/mL), diphtheria (diphtheria
antitoxin 0.01 IU/mL), tetanus (tetanus antitoxin 0.01 EU/mL) and poliomyelitis types 1, 2 and
3 (poliovirus neutralizing antibody titre 1:8). (See Table 12.)
Types 1, 2 and 3 Measured One Month After the Third Dose of the Primary Series and
Immediately Before and One Month After a Fourth Dose with PEDIACEL in Clinical
Trial PB9602 (7)
Post 3rd Dose
(7 months)
N = 108
Pre 4th Dose

(18 19 months)
N = 98
Post 4th Dose

(19 20 months)
N = 98
6.18
0.64
42.89
(4.69, 8.15)
(0.48, 0.84)
(33.30, 55.25)
% 0.15 g/mL
97.2
84.4
100.0
% 1.0 g/mL
90.7
39.6
99.0
GMC
0.38
0.07
4.50
(0.31, 0.46)
(0.05, 0.09)
(3.54, 5.73)
% 0.01 IU/mL
100.0
98.0
100.0
% 0.10 IU/mL
86.1
40.8
100.0
GMC
3.80
0.60
11.71
(3.20, 4.52)
(0.49, 0.73)
(9.76, 14.04)
% 0.01 EU/mL
100.0
100.0
100.0
% 0.10 EU/mL
100.0
95.8
100.0
GMT
1,290
170
7,852
(945, 1,762)
(125, 231)
(6,096, 10,112)
% 1:4
100.0
% 1:8
100.0
95.9
100.0
GMT
4,089
516
22,365
(3,008, 5,559)
(379, 702)
(18,227, 27,443)
% 1:4
100.0
% 1:8
100.0
100.0
100.0
GMT
2,255
314
22,208
(1,644, 3,093)
(227, 434)
(16,067, 30,695)
% 1:4
100.0
% 1:8
100.0
100.0
100.0
Antibody
Result
GMC
Anti-PRP
Diphtheria
Tetanus
Polio Type 1
Polio Type 2
Polio Type 3
(95% CI)
(95% CI)
(95% CI)
(95% CI)
(95% CI)
(95% CI)
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315 PEDIACEL
Seroconversion rates (% 4-fold rise) were high for each of the pertussis antibodies after the
primary series. (See Table 13.) A robust booster response was observed after the fourth dose for
all the vaccine antigens. (See Table 12 and Table 13.)
Table 13: Pertussis Antibody Responses Measured One Month After the Third Dose of the
Primary Series and Immediately Before and One Month After a Fourth Dose with
PEDIACEL in Clinical Trial PB9602 (7)
Antibody
Pre 4th Dose

(18 19 months)
N = 98
Post 4th Dose

(19 20 months)
N = 98
103.8
12.0
259.5
(91.7, 117.5)
(10.22, 14.08)
(223.4, 301.6)
% 4-fold rise*
91.3
99.0
GMC (EU/mL)
221.2
22.68
258.1
(198.9, 246.0)
(18.84, 27.30)
(227.6, 292.7)
% 4-fold rise*
92.3
90.8
GMC (EU/mL)
86.3
8.09
215.0
(68.1, 109.3)
(6.11, 10.72)
(171.5, 269.4)
% 4-fold rise*
83.0
96.9
GMC (EU/mL)
370.2
44.28
1,287
(297.9, 460.2)
(35.03, 55.96)
(1,073, 1,543)
91.2
94.9
Result
GMC (EU/mL)
PT
(95% CI)
FHA
PRN
FIM
(95% CI)
(95% CI)
(95% CI)
% 4-fold rise*
Post 3rd Dose

(7 months)
N = 108
Percentage of vaccinees attaining at least a 4-fold increase over their pre-immunization antibody level.
Safety
Solicited injection site reactions occurred in 14.6% (redness) to 32.3% (tenderness) of
PEDIACEL vaccinees. Severe injection site reactions were observed in only 1.8% (tenderness)
to 15.2% (redness). (See Table 14.) As seen in study PB9502 the frequency of injection site
reactions were generally higher after the fourth dose than in the previous three doses in infants,
however severe tenderness did not increase with the fourth dose. Systemic adverse reactions
occurred in 3.0% (vomiting) to 51.8% (fussiness). Except for fussiness (2.7%) and crying (1.9%)
severe systemic reactions were uncommon and there were no reports of fever 40C. (See Table
14.)
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315 PEDIACEL
Single Dose with PEDIACEL Administered at 2, 4, 6 and 18 Months of Age in Clinical
Trial PB9602 (7)
Solicited Reaction
Crying
Any
Severe*
Less Active
Any
Severe
Eating Less
Any
Severe
Diarrhea
Any
Severe
Fever
Any
40C
Fussiness
Any
Severe**
2 months
N = 110
4 months
N = 110
6 months
N = 108
18 months
N = 98
23.6
34.6
25.0
19.2
1.8
1.9
1.0
30.9
24.6
16.7
14.1
20.9
20.0
18.5
18.2
9.1
4.6
6.1
12.7
20.9
15.7
22.4
45.5
51.8
41.7
33.3
2.7
1.9
1.0
14.6
25.5
28.7
34.3
4.5
5.5
4.6
15.2
10.0
Injection Site
Redness
Any
Injection Site
Swelling
Any
20.9
16.4
22.2
23.2
35 mm
10.0
1.8
5.6
12.1
Injection Site
Tenderness
Any
20.9
22.7
16.7
32.3
Severe
2.7
1.8
1.9
1.0
Vomiting
Any
3.6
3.6
5.6
3.0
Severe
**
35 mm
Cried continuously for 3 hours.

Sleeping most of the time.
Refused most or all feeds.
Multiple liquid stools without any solid consistency.
Continuously fussy for 3 hours.
Baby cried when leg is moved.
Frequent vomiting and inability to have any oral intake.
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Clinical Trial U01-A5I-302

Immunogenicity
In a randomized, controlled clinical trial conducted in the United Kingdom (U01-A5I-302), 3
doses of PEDIACEL were administered to infants concomitantly with 3 doses of either a
meningococcal group C CRM197 conjugate vaccine (MCC-CRM; N=60) or a meningococcal
group C tetanus toxoid conjugate vaccine (MCC-TT; N=61). The vaccines were administered
according to the UK immunization schedule at 2, 3, and 4 months of age without a booster in the
second year of life.
One month after the third dose, anti-PRP responses in infants who received MCC-CRM were
lower in comparison to those who received MCC-TT: 88.0% (95%CI: 76.2, 94.4) vs 98.1%
(95%CI: 90.1, 99.7) achieved an anti-PRP concentration of at least 0.15 g/mL, with GMCs of
1.26 g/mL (95%CI: 0.75, 2.13) and 3.67 g/mL (95%CI: 2.56, 5.26). PEDIACEL did not
affect the proportions of infants with meningococcal group C serum bactericidal antibody (SBA)
titres of at least 1:8 (measured with rabbit complement) when co-administered with MCC-CRM
or MCC-TT; at least 98% of the infants attained seroprotective levels against meningococcal
group C. The Men C SBA GMTs in infants who received concomitant MCC-TT were lower in
comparison to those observed with MCC CRM-197: 690 (95%CI: 418, 1140) vs 2165 (95%CI:
1517, 3089), respectively. The clinical significance of these differences is unknown. (7) (29) (30)
Safety
Following each vaccination, solicited injection site reactions within the first seven days of
vaccination occurred in 13.2% (tenderness) to 38.0% (redness) of PEDIACEL vaccinees. Severe
injection site reactions were observed in 4.1% (tenderness) to 12.4% (redness). The frequency of
reactions at the injection site was similar after each dose, although tenderness was lower at the
second and third dose. Solicited systemic reactions within 7 days after vaccination occurred in
9.1% (fever 37.5C) to 60.3% (irritability), and tended to decrease with each vaccination. Severe
systemic reactions were observed in 0% (fever and diarrhea) to 14.9% (irritability). No child
immunized with PEDIACEL experienced a fever 39.5C. (7)
ADDITIONAL RELEVANT INFORMATION
Simultaneous vaccination with combination vaccines during early childhood has been the
cornerstone of Canadas immunization program for many years. PEDIACEL combines five
childhood vaccines and offers protection against diphtheria, tetanus, pertussis, poliomyelitis and
invasive Hib disease. Immunization with these antigens has been associated with a striking
decrease in the incidence of morbidity and mortality caused by these infections. PEDIACEL is a
fully liquid version of PENTACEL with both vaccines containing similar antigens.
PENTACEL has been licensed in Canada since 1997 with over 13 million doses administered to
children in Canada. (7)
Diphtheria and Tetanus: The information provide below is consistent with NACI
recommendations. (1)
Diphtheria is a serious communicable disease caused by exotoxin-producing strains of the
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315 PEDIACEL
bacterium C. diphtheriae. Symptoms result from local infection of the respiratory tract, which
may lead to breathing difficulties, or infection of the skin or mucosal surfaces, or from
dissemination of diphtheria toxin, which damages the heart and central nervous system. Routine
immunization against diphtheria in infancy and childhood has been widely practised in Canada
since 1930, resulting in a decline in morbidity and mortality. In Canada, there are 0 to 5 isolates
reported each year. The case fatality rate remains at about 5 to 10%, with the highest death rates
in the very young and elderly. The disease occurs most frequently in unimmunized or partially
immunized persons. (1)
Tetanus is an acute and often fatal disease caused by an extremely potent neurotoxin produced by
C. tetani. The organism is ubiquitous and its occurrence in nature cannot be controlled.
Immunization is highly effective, provides long-lasting protection, and is recommended for the
whole population. Between 1980 and 2004, the number of cases reported annually in Canada
ranged from 1 to 10, with an average of 4 cases per year. (1)
Both diphtheria and tetanus toxoids are prepared by detoxification of the respective toxins with
formaldehyde. Intramuscular injection of diphtheria and tetanus toxoids results in the production
of protective antibodies against the toxins and their lethal effects, but it does not preclude local
infections by the bacteria. (1) After completion of a primary series, circulating antibodies to
tetanus and diphtheria toxoids gradually decline but are thought to persist at protective levels for
up to 10 years. (1) The National Advisory Committee on Immunization (NACI) continues to
recommend tetanus and diphtheria boosters every 10 years based on concern regarding the decline
of antibody levels with age and potential failure of single booster doses to produce protective
levels in older individuals. (1)
Pertussis: Pertussis (whooping cough) results from an acute infection of the respiratory tract
caused by B. pertussis. Severity and mortality are greatest in infancy and even infants born to
apparently immune mothers are highly susceptible to infection, particularly if maternal immunity
was induced by whole-cell pertussis vaccine.
Whole-cell pertussis vaccine was first introduced in Canada in 1943. NACI states that over the
past 64 years, pertussis incidence has declined by over 90%, although outbreaks of pertussis
continue to arise. Because of concerns about the frequency and severity of systemic and injection
site adverse reactions with whole-cell pertussis vaccines, acellular pertussis vaccines have
replaced whole-cell formulations in Canada. Acellular vaccines provoke significantly fewer
injection site reactions, lower rates of fever and fewer episodes of unusual or persistent crying. (7)
(26) (27) (31)
PEDIACEL contains a five component acellular pertussis vaccine stimulating immune response
to PT, FHA, PRN and FIM. In an efficacy trial, five-component acellular pertussis vaccines were
significantly more efficacious than other acellular pertussis formulations containing fewer
antigens. (7) (26) (32)
Poliomyelitis: Poliomyelitis is caused by infection with one of the three antigenic types of
poliovirus. Following introduction of poliovirus vaccine in Canada in 1955, the indigenous
disease has been virtually eliminated. However, the persistence of wild virus cases in polio
endemic regions of Africa and Asia (33) necessitates that the highest possible level of vaccineinduced immunity be maintained in the Canadian population.
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315 PEDIACEL
Inactivated Poliomyelitis Vaccine (Vero Cell Origin) and its combinations have been studied in
more than 5,000 infants as a primary immunizing agent and in more than 1,000 children and
adults as a booster vaccine. Seroconversion rates ranged from 74 to 100% for all 3 types after two
doses and usually over 90% after three doses. (34) Since 1982, more than 90 million doses of
Inactivated Poliomyelitis Vaccine (Vero Cell Origin) have been used, either alone or in
combination with other vaccines.
Haemophilus influenzae type b: Before the introduction of Haemophilus b conjugate vaccines in
Canada, H. influenzae type b (Hib) was the most common cause of bacterial meningitis and a
leading cause of other serious infections in young children. Four hundred and eighty-five cases
were recorded in 1985 before the first vaccine was available. (35) After 1997 when routine infant
immunization with PENTACEL (same Hib conjugate as PEDIACEL) began, only 8 - 10 cases
a year were reported. Only a single case of Hib infection in a child fully vaccinated with
PENTACEL was reported to Canadas nationwide vaccine surveillance system in 1999. (36) In
2000, case reports of Haemophilus b meningitis reached an historical low with only 4 cases
reported, a reduction of 99% from pre-vaccine levels. (35)
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REFERENCES
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
National Advisory Committee on Immunization (NACI). General guidelines. Vaccine safety

and adverse events following immunization. Recommended immunization. Diphtheria
toxoid. Haemophilus vaccine. Pertussis vaccine. Tetanus toxoid. In: Canadian Immunization
Guide. 7th ed. Her Majesty the Queen in Right of Canada, represented by the Minister of
Public Works and Government Services Canada. 2006. p. 40,73,80-4,94,113,166-171,1728,257-266,309-16.
CDC. General recommendations on immunization: Recommendations of the Advisory
Committee on Immunization Practices (ACIP). MMWR 2006;55(RR-15):1-48.
Plotkin SA, Orenstein WA. In: Vaccines. 4th ed. Philadelphia, PA: W.B. Saunders 2004. p.
214,229-68,485,518-19,745-81.
Stratton KR, et al. editors. Immunization safety review: vaccinations and sudden
unexpected death in infancy. Washington, DC: National Academy Press;2003. p. 17-84.
CDC. Diphtheria, tetanus and pertussis: recommendations for vaccine use and other
preventive measures. Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 1991;40(RR-10):1-28.
Stratton KR, et al. editors. Adverse events associated with childhood vaccines; evidence
bearing on causality. Washington: National Academy Press; 1994. p. 67-117.
Data on file at Sanofi Pasteur Limited.
Rothstein EP, et al. Comparison of antigenuria after immunization with three Haemophilus
influenzae type b conjugate vaccines. Pediatr Infect Dis J 1991;10:311-4.
Storsaeter J, et al. Levels of anti-pertussis antibodies related to protection after household
exposure to Bordetella pertussis. Vaccine 1998;16(20):1907-16.
Cherry JD, et al. A search for serologic correlates of immunity to Bordetella pertussis
cough illnesses. Vaccine 1998;16(20):1901-6.
Deen JL, et al. Household contact study of Bordetella pertussis infections. Clin Infect Dis
1995;21(5):1211-9.
Preston NW, Standbridge TN. Efficacy of pertussis vaccines: a brighter horizon. Br Med J
1972;3:448-51.
Efficacy of whooping-cough vaccines used in the United Kingdom before 1968. Br Med J
1973;1:259-62.
Ramkissoon A, et al. Subclinical pertussis in incompletely vaccinated and unvaccinated
infants. S Afr Med J 1995;85(7):662-7.
Bettinger JA, et al. The effect of changing from whole-cell to acellular pertussis vaccine on
the epidemiology of hospitalized children with pertussis in Canada. Pediatr Infect Dis J
2007;26:31-5.
Kandola K, et al. A comparison of pertussis rates in Northwest Territories: pre- and postacellular pertussis vaccine introduction in children and adolescents. Can J Infect Dis Med
Microbiol 2005;16(5):271-4.
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17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
Public Health Agency of Canada. Pertussis in Newfoundland and Labrador: 1991-2004. Can
Comm Dis Rep. 2005;31:1-3.
Skowronski DM, et al. The changing age and seasonal profile of pertussis in Canada. J
Infect Dis 2002;185:1448-53.
Plotkin SA. Immunologic correlates of protection induced by vaccination. Pediatr Infect
Dis J 2001;20:63-75.
Peltola H, et al. Prevention of Haemophilus influenzae type b bacteremic infections with the
capsular polysaccharide vaccine. N Engl J Med 1984;310:1561-6.
Stainer DW. Production of diphtheria toxin. In: Manclark CR, editor. Proceedings of an
informal consultation on the World Health Organization requirements for diphtheria,
tetanus, pertussis and combined vaccines. United States Public Health Service, Bethesda,
MD. DHHS 91-1174. 1991. p. 7-11.
Mueller JH, et al. Variable factors influencing the production of tetanus toxin. J Bacteriol
1954;67(3):271-7.
Stainer DW, et al. A simple chemically defined medium for the production of phase I
Bordetella pertussis. J Gen Microbiol 1971;63:211-20.
Chu CY, et al. Further studies on the immunogenicity of Haemophilus influenzae type b and
pneumococcal type 6A polysaccharide-protein conjugates. Infect Immun 1983;40:245-56.
Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible
medium. J Immunol 1941;40:21-32.
Gustaffson L, et al. A controlled trial of a two-component acellular, a five-component
acellular and a whole-cell pertussis vaccine. N Engl J Med 1996;334:349-55.
Olin P, et al. A controlled trial of two-component, three-component and five-component
acellular pertussis vaccines compared with whole-cell pertussis vaccine. Lancet
1997;350(9091):1569-77.
Greco D, et al. A controlled trial of two acellular vaccines and one whole-cell vaccine
against pertussis. N Engl J Med 1996;334:341-8.
Pollard AJ. New combination vaccines still need a boost. Arch Dis Child. 2007;92:1-2.
Kitchin NR, Southern J, Morris R, Hemme F, Thomas S, Watson MW, et al. Evaluation of a
diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b
vaccine given concurrently with meningococcal group C conjugate vaccine at 2, 3 and 4
months of age. Arch Dis Child. 2007;92:11-6.
Decker MD, et al. Comparison of 13 acellular pertussis vaccines: adverse reactions.
Pediatrics 1995;96(3):557-66.
Cherry JD. Comparative efficacy of acellular pertussis vaccines; an analysis of recent trials.
Pediatr Infect Dis J 1997;16:S90-96.
World Health Organization. Polio News. 2002;16:2.
Vidor E, et al. Fifteen years of experience with Vero-produced enhanced potency
inactivated poliovirus vaccine. Pediatr Infect Dis J 1997;16:312-22.
Scheifele D, et al. Historic low Haemophilus influenzae type b case tally - Canada 2000.
CCDR 2001;27(18):149-150.
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36
Scheifele D, et al. Haemophilus influenzae type b disease control using PENTACEL,

Canada, 1998 - 1999. CCDR 2000;26(11):93-6.
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Vaccine Information Service: 1-888-621-1146 or 416-667-2779. Business Hours: 8 a.m. to 5 p.m.

Eastern Time Monday to Friday.
Product information as of February 2012.
Manufactured by:
R11-0212 Canada
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315 PEDIACEL
IMPORTANT: PLEASE READ
PART III: CONSUMER

INFORMATION
PEDIACEL
Diphtheria and Tetanus Toxoids and Acellular
Pertussis Vaccine Adsorbed Combined with
Inactivated Poliomyelitis Vaccine and
Haemophilus b Conjugate Vaccine
This leaflet is part III of a three-part "Product
Monograph" published when PEDIACEL was
approved for sale in Canada and is designed
specifically for Consumers. This leaflet is a summary
and will not tell you everything about PEDIACEL.
Contact your doctor, nurse or pharmacist if you have
any questions about the vaccine.
ABOUT THIS VACCINE

What the vaccine is used for:
PEDIACEL is a vaccine that is used to help prevent
diphtheria, tetanus (lock jaw), pertussis (whooping
cough), polio and invasive H. influenzae type b (Hib)
infections. This vaccine may be given to children aged
2 months or older. It may also be given as a booster to
children up to age 7.
The majority of children who are vaccinated with
PEDIACEL will produce enough antibodies to help
protect them against these 5 diseases. However, as
with all vaccines, 100% protection cannot be
guaranteed.
What it does:
What the medicinal ingredient is:

Each 0.5 mL dose of PEDIACEL contains:
diphtheria toxoid, tetanus toxoid, acellular pertussis
vaccine (pertussis toxoid, filamentous
haemagglutinin, fimbriae types 2 and 3, pertactin),
inactivated polio vaccine, Hib conjugate vaccine.
What the non-medicinal ingredients are:
Aluminum phosphate, 2-phenoxyethanol, polysorbate
80, bovine serum albumin, trace amounts of
formaldehyde, glutaraldehyde, neomycin,
streptomycin and polymyxin B.
What dosage forms it comes in:
PEDIACEL is a liquid vaccine that is injected into a
muscle. A single dose is 0.5 mL.
WARNINGS AND PRECAUTIONS

If your child has any of the following conditions, talk
to your doctor or pharmacist BEFORE the child
receives PEDIACEL:
A high fever or serious illness. Wait until the

child is better to give the vaccination.
An allergy to any component of the vaccine or

the container.
A serious nervous system adverse event

following a previous pertussis vaccination.
Diseases of the immune system or who are

taking a medical treatment that affects the
immune system. The vaccine may provide your
child with a lower level of protection than it does
for people with healthy immune systems. If
possible, try to postpone the vaccination until
after your child has completed the treatment.
A bleeding disorder or take blood-thinning

medications. Tell the person giving the injection
about your childs condition. The injection must
be done carefully to prevent excessive bleeding.
PEDIACEL causes the body to produce its own

natural protection against diphtheria, tetanus, pertussis
(whooping cough), poliomyelitis and invasive Hib
infections. After your child receives the vaccine, the
body begins to make substances called antibodies.
Antibodies help the body to fight disease. If a
vaccinated person comes into contact with one of the
germs that cause these diseases, the body is usually
ready to destroy it.
When it should not be used:
Do not give PEDIACEL to a child who has an

allergy to any ingredient in the vaccine or has had
an allergic reaction after receiving a vaccine that
contained similar ingredients.
Do not give PEDIACEL to a person who has

had a serious nervous system disorder within 7
days after a previous pertussis vaccine. In case of
progressive nervous system disorder or
uncontrolled epilepsy, vaccination may be
considered only after a treatment has been
established and the condition is stabilized.
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315 PEDIACEL
A higher risk of seizure than the general

population. A fever-reducing medication may be
given to your child.
INTERACTIONS WITH THIS

VACCINE
DO NOT mix PEDIACEL with other vaccines or
medicinal products in the same syringe.
PROPER USE OF THIS VACCINE

Usual Dose
A single dose of 0.5 mL is recommended for routine
immunization of infants at 2, 4, 6 and 18 months of
age and in children up to their 7th birthday.
The vaccination should be given in the muscle,
preferably in the thigh for children up to 1 year-old. In
children >1 year of age, the shoulder is the preferred
site since use of the thigh results in limping due to
muscle pain.
SIDE EFFECTS AND WHAT TO DO

ABOUT THEM
A vaccine, like any medicine, may cause side effects.
Up to one third of children who receive PEDIACEL
may have mild side effects such as redness, swelling
or tenderness around the injection site. Other common
reactions include fever, increased crying, fussiness,
being less active and decreased eating. These side
effects are usually mild and last no more than 3 to 4
days. Severe reactions, such as high fever, swelling
and redness of the entire arm or leg, or a serious
allergic reaction are very rare.
Tell your doctor, nurse or pharmacist as soon as
possible if your child is not feeling well after
receiving PEDIACEL.
Serious side effects are extremely rare.
This is not a complete list of side effects. For any
unexpected effects while taking PEDIACEL, contact
your doctor, nurse or pharmacist.
Overdose
In case of drug overdose, contact a health-care
practitioner, hospital emergency department or
regional Poison Control Centre immediately, even if
there are no symptoms.
HOW TO STORE IT
Missed Dose
Do not use after the expiration date.
If immunization is delayed for any reason the

recommended schedule is:
Keep out of reach of children.
3 single doses of 0.5 mL with 2 months between

doses
a 4th dose given 6 to 12 months after the 3rd dose.
Store the vaccine in a refrigerator at 2 to 8C (35 to

46F). Do not freeze. Throw the product away if it
has been exposed to freezing.
Page 41 of 42
sanofi pasteur
315 PEDIACEL
REPORTING SUSPECTED SIDE

EFFECTS
To monitor vaccine safety, the Public Health Agency
of Canada collects case reports on adverse events
following immunization.
For Health Care Professionals:
If a patient experiences an adverse event following
immunization, please complete the appropriate
Adverse Events following Immunization (AEFI)
Form and send it to your local Health Unit in your
province/territory.
For the General Public:
Should your child experience an adverse event
following immunization, please ask your doctor,
nurse, or pharmacist to complete the Adverse Events
following Immunization (AEFI) Form.
MORE INFORMATION
This document plus the full product monograph,
prepared for health professionals can be found at:
www.sanofipasteur.ca
You may also contact the vaccine producer,
Sanofi Pasteur Limited, for more information.
Telephone: 1-888-621-1146 (no charge) or
416-667-2779 (Toronto area).
Business Hours: 8 a.m. to 5 p.m. Eastern Time
Monday to Friday.
This leaflet was prepared by Sanofi Pasteur Limited.
Last revised: February 2012.
R11-0212 Canada
If you have any questions or have difficulties

contacting your local health unit, please contact
Vaccine Safety Section at Public Health Agency of
Canada:
By toll-free telephone: (1-866-844-0018)
By toll-free fax:
(1-866-844-5931)
Email: caefi@phac-aspc.gc.ca
Web: http://www.phac-aspc.gc.ca/im/vs-sv/indexeng.php
Mail:
The Public Health Agency of Canada
Vaccine Safety Section
130 Colonnade Road
A/L 6502A
Ottawa, Ontario
K1A 0K9
NOTE: Should you require information related to
the management of the side effect, please contact
your health-care provider before notifying the
Public Health Agency of Canada. The Public
Health Agency of Canada does not provide
medical advice
Page 42 of 42

Pediacel Vaccine Detailed Manufacturer Information

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sanofi pasteur

Section 1.3.1 Product Monograph

Sanofi Pasteur Limited

Date of Approval: March 2012

Section 1.3.1 Product Monograph

Section 1.3.1 Product Monograph

Clinical Trial PB9602 ............................................................................................................29

Clinical Trial U01-A5I-302 ...................................................................................................33

ADDITIONAL RELEVANT INFORMATION ....................................................................33

Section 1.3.1 Product Monograph

INTERACTIONS WITH THIS VACCINE...........................................................................41

Section 1.3.1 Product Monograph

PART I: HEALTH PROFESSIONAL INFORMATION

Section 1.3.1 Product Monograph

INDICATIONS AND CLINICAL USE

Section 1.3.1 Product Monograph

Acute Neurological Disorders

Section 1.3.1 Product Monograph

Temperature of 40.5C (105F) within 48 hours, not attributable to another identifiable

Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours;

Persistent crying lasting 3 hours within 48 hours;

Convulsions with or without fever within 3 days.

Section 1.3.1 Product Monograph

vaccination of persons with chronic immunodeficiency such as HIV infection is recommended

Section 1.3.1 Product Monograph

Injection Site Reactions

Data from Post-Marketing Experience

Section 1.3.1 Product Monograph

Section 1.3.1 Product Monograph

Section 1.3.1 Product Monograph

Section 1.3.1 Product Monograph

Section 1.3.1 Product Monograph

same formulation in pertussis antigens as PEDIACEL was demonstrated to provide a two-fold to

Section 1.3.1 Product Monograph

Section 1.3.1 Product Monograph

Manufacturing Process Residuals

Section 1.3.1 Product Monograph

PART II: SCIENTIFIC INFORMATION

Section 1.3.1 Product Monograph

Section 1.3.1 Product Monograph

Randomized, placebocontrolled, double-blind,

Section 1.3.1 Product Monograph

** Act-HIB [Haemophilus b Conjugate Vaccine (Tetanus Protein Conjugate)].

Sweden I Efficacy Trial

Vaccine Efficacy (%) of TRIPACEL (N = 2,551)

cough >7 days

paroxysmal cough 14 days

paroxysmal cough 21 days

Section 1.3.1 Product Monograph

Section 1.3.1 Product Monograph

Section 1.3.1 Product Monograph

Section 1.3.1 Product Monograph

Post 4th Dose

Section 1.3.1 Product Monograph

Section 1.3.1 Product Monograph

Section 1.3.1 Product Monograph

Cried continuously for 3 hrs.

Section 1.3.1 Product Monograph

Clinical Trial PB9602