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PEDIACEL SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): DIPHTHERIA TOXOID ADSORBED / HAEMOPHILUS INFLUENZAE TYPE B POLYRIBOSYLRIBITOL PHOSPHATE / HAEMOPHILUS INFLUENZAE TYPE B POLYSACC.-TETANUS TOXOID CONJ. / PERTACTIN ADSORBED PURIFIED / PERTUSSIS ADSORBED PURIFIED FILAMENTOUS HAEMAGGLUTININ / PERTUSSIS PURIFIED F

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
PEDIACEL, suspension for injection in pre-filled syringe
Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis
(inactivated) and Haemophilus type b conjugate vaccine (adsorbed)

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL dose contains:
Diphtheria Toxoid1
Tetanus Toxoid

not less than 30 IU

1

not less than 40 IU
1

Acellular Pertussis Antigens
Pertussis Toxoid (PT)
Filamentous Haemagglutinin (FHA)

20 micrograms
20 micrograms

Pertactin (PRN)
Fimbriae Types 2 and 3 (FIM)

3 micrograms
5 micrograms

Poliovirus (Inactivated)2
Type 1 (Mahoney)

40 D antigen units3

Type 2 (MEF-1)

8 D antigen units3

Type 3 (Saukett)

32 D antigen units3

Haemophilus influenzae Type b Polysaccharide
(Polyribosylribitol Phosphate)
10 micrograms
Conjugated to Tetanus Toxoid (PRP-T)
18-30 micrograms
1

adsorbed on aluminium phosphate

1.5 mg

(0.33 mg aluminium)
2
3

Produced in Vero cells.
or equivalent antigenic quantity determined by a suitable immunochemical

method.
For a full list of excipients, see section Error! Reference source not found..

3

PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe
PEDIACEL is a uniform, cloudy, white to off-white suspension.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
PEDIACEL is indicated for primary and booster vaccination against
diphtheria, tetanus, pertussis, poliomyelitis and invasive Haemophilus
influenzae type b disease in infants and children from the age of 6 weeks up to
the fourth birthday. PEDIACEL should be used in accordance with applicable
official recommendations.

4.2

Posology and method of administration
Posology
Paediatric population
Primary Vaccination
The primary vaccination series consists of 2 or 3 doses of 0.5 mL and may be
commenced from 6 weeks of age according to applicable official
recommendations. There should be an interval of at least one month between
doses.
Booster Vaccination
After primary series vaccination with either 2 doses (e.g., 3, 5 months) or 3
doses (e.g., 2, 3, 4 months) of PEDIACEL, a booster dose should be given at
least 6 months after the last priming dose in accordance with applicable
official recommendations.
PEDIACEL can be considered for the booster if the composition is in
accordance with the applicable official recommendations.
Based on safety and immunogenicity data from clinical studies, PEDIACEL
should preferably be given to children who received the same vaccine in
infancy. However, PEDIACEL may be given as a booster to children who
received other diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus
influenzae type b (Hib) with or without hepatitis B vaccines in their primary
series.
Children less than 6 weeks of age: The safety and efficacy of PEDIACEL in
children less than 6 weeks of age has not been established. No data are
available
Children 4 years of age or older: The safety and efficacy of PEDIACEL in
children 4 years of age or older has not been established. No data are available
Method of administration
PEDIACEL should be administered intramuscularly. The recommended
injection sites are the anterolateral aspect of the thigh or the deltoid region of

the upper arm if there is adequate muscle mass, according to local clinical
practice recommendations. The anterolateral aspect of the thigh is the preferred site
for infants under one year of age.

Do not administer PEDIACEL by intravascular injection; ensure that the
needle does not penetrate a blood vessel. Do not administer subcutaneously.
Precautions to be taken before handling or administering the medicinal
product
For instructions for preparation of the medicinal product before
administration, see section 6.6.

4.3

Contraindications
Hypersensitivity to the active substances, to any of the excipients listed in
section 6.1 or to any residual substances carried over from manufacture
(neomycin, streptomycin, polymyxin B, glutaraldehyde, formaldehyde and
bovine serum albumin), which may be present in undetectable trace amounts.
PEDIACEL is contraindicated if the infant has experienced an encephalopathy
of unknown aetiology, occurring within 7 days following previous vaccination
with pertussis containing vaccine. In these circumstances pertussis vaccination
should be discontinued and the vaccination course should be continued with
diphtheria, tetanus, polio and Hib vaccines.
PEDIACEL is contraindicated in infants with a progressive neurologic
disorder, including infantile spasms, uncontrolled epilepsy, progressive
encephalopathy. Pertussis vaccine should not be administered to children with
such conditions until a treatment regimen has been established and the
condition has stabilized.
As with other vaccines, administration of PEDIACEL should be postponed in
children suffering from acute severe febrile illness. The presence of a minor
infection (e.g., mild upper respiratory infection) is not a contraindication.

4.4

Special warnings and precautions for use
Applicable official recommendations for childhood immunizations should be
consulted before administering this vaccine to children in or after the second
year of life since the exact combination of antigens may not be considered
appropriate and/or necessary after completion of the primary vaccination
series.
Prior to immunization
As with all injectable vaccines, appropriate medical treatment and supervision
should be readily available for immediate use in case of a rare anaphylactic
reaction following the administration of the vaccine (see section 4.8).
If any of the following events have occurred after administration of a
pertussis-containing vaccine, the decision to administer PEDIACEL should be
based on careful consideration of potential benefits and possible risks.


Temperature of ≥40°C 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.

If Guillain-Barré syndrome or brachial neuritis has occurred following receipt
of prior vaccine containing tetanus toxoid, the decision to give any vaccine
containing tetanus toxoid should be based on careful consideration of the
potential benefits and possible risks.
A history of febrile convulsions, a family history of convulsions or Sudden
infant death syndrome (SIDS) do not constitute a contraindication for the use
of PEDIACEL. Vaccines with a history of febrile convulsions should be
closely followed up as such adverse events may occur within 2 to 3 days post
vaccination.
The potential risk of apnoea 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.
Immunocompromised children (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. HIV infection is not considered as a
contraindication. The expected immunological response may not be obtained
after vaccination of immunosuppressed patients.
Administration precautions
As for all injectable products, the vaccine should be administered with caution
to children with thrombocytopenia or bleeding disorders since bleeding may
occur following an intramuscular injection.
Other considerations
As with any vaccine, a protective immune response may not be elicited in all vaccines
(see section 5.1).

Vaccines that contain Hib antigen do not provide protection against infections
caused by other types of Haemophilus influenzae or against meningitis of
other origin.
Granuloma or sterile abscess at the injection site has been reported with
vaccines containing aluminium.
Since the Hib capsular polysaccharide antigen is excreted in the urine, a
positive urine test can be observed within 1-2 weeks following vaccination.
Other tests should be performed in order to confirm Hib infection during this
period.

4.5

Interaction with other medicinal products and other forms of interaction
Concomitant vaccine administration
PEDIACEL may be administered at the same time as, but as a separate
injection to, any of the following monovalent or combination vaccines:
hepatitis B, 7-valent pneumococcal conjugate, measles, mumps and rubella
(MMR), varicella or meningococcal group C conjugate vaccines. Injections
should be made into separate sites and, preferably, into separate limbs.
Meningococcal Group C Conjugate Vaccines
In a controlled clinical study PEDIACEL was administered concomitantly
with two different meningococcal group C conjugate vaccines (a
meningococcal group C CRM197 conjugate and a meningococcal group C
tetanus toxoid conjugate vaccine) at 2, 3 and 4 months of age. Although
seroprotection rates were high in both groups (>88.0% anti-PRP 0.15
micrograms/mL), antibody responses to the Hib component of PEDIACEL
(PRP conjugated to tetanus toxoid) were lower when co-administered with a
meningococcal group C CRM197 conjugate vaccine than with a meningococcal
group C tetanus toxoid conjugate vaccine. 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 either a CRM197 conjugate or a tetanus toxoid conjugate
vaccine. (See Section 5.1)
Vaccine/drug interactions
Immunosuppressive treatments may interfere with the development of the
expected immune response. (See Section 4.4)

4.6

Fertility, Pregnancy and lactation
Not applicable. This vaccine is not intended for administration to women of
child-bearing age.

4.7

Effects on ability to drive and use machines
Not relevant.

4.8

Undesirable effects
a. Summary of the Safety Profile
The data from 11 clinical trials conducted in several countries and using various
immunization schedules were pooled. In these studies, PEDIACEL was administered
in a primary series (N = 1487) and as a booster dose (N = 1632). The adverse
reactions occurring after vaccination are summarised in Table 1 below.

The most frequently reported adverse reactions after PEDIACEL administration were
decreased activity, injection site reactions (tenderness, erythema, swelling), pyrexia
(≥38oC), vomiting, abnormal crying, appetite loss, and irritability.
Adverse reactions spontaneously reported following the commercial use of
PEDIACEL are also summarised in Table 1 below. Because these reactions are
reported voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency.
b. Tabulated list of adverse reactions
Adverse reactions are ranked under headings of frequency using the following
convention:
Very common (≥1/10)
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1,000 to <1/100)
Rare
(>1/10,000 to <1/1,000)
Very Rare
(<1/10,000), including individual cases
Not known: cannot be estimated from available data.
Table 1: List of Adverse Reactions
Adverse Reactions

Frequency

Immune System Disorders
Hypersensitivity

Not known

Anaphylactic reaction (such as urticaria, angioedema).
Metabolism and Nutrition Disorders
Appetite loss

Very common

Psychiatric Disorders
Irritability

Very common

Abnormal crying

Very common

Nervous System Disorders
Convulsion (with or without fever)

Uncommon

High-pitched crying
*Hypotonic hyporesponsive episode (infant appears pale, hypotonic (limp) and
unresponsive).

Not known

Somnolence
Vascular Disorders
Pallor

Not known

Respiratory, Thoracic and Mediastinal Disorders
Apnoea

Not known

Gastrointestinal Disorders
Vomiting

Very common

Diarrhoea

Common

Skin and Subcutaneous Tissue Disorders

Rash

Not known

Musculoskeletal, Connective Tissue and Bone Disorders
Pain in vaccinated limb

Not known

General Disorders and Administration Site Conditions
Decreased activity
Injection site tenderness
Injection site erythema

Very common

Pyrexia (>38°C),
Injection site swelling
Injection site bleeding

Common

Injection site bruising
Extensive limb swelling (from the injection site beyond one or both joints)

Uncommon

Pyrexia (>40.5°C),
Injection site mass
Asthenia

Not known

Listlessness
Edematous reactions affecting one or both lower limbs
*To date, this condition has not been associated with any permanent sequelae.
c. Description of selected adverse reactions
Edematous reactions affecting one or both lower limbs have occurred following
vaccination with H. influenzae type b containing vaccines. When this reaction occurs,
it 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.
d. Other Special Populations
Apnoea in very premature infants (≤28 weeks of gestation). (See section Error!
Reference source not found.)
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

4.9

Overdose
Not applicable.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Bacterial and viral vaccines combined,
diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus, ATC
code J07CA06.
Immunogenicity
In a randomized, single-blind, controlled multi-centre clinical trial, the
immunogenicity of PEDIACEL was compared to another DTaP-IPV+Hib
vaccine when administered to infants using the three-dose primary
immunization schedule of 2, 3 and 4 months with a booster dose given at 1218 months. Antibody responses one month after completion of the three-dose
primary series and one month after the booster dose of PEDIACEL are
summarized below.
Table 2: Immune

Antigen
Diphtheria
Tetanus
Pertussis
Pertussis Toxoid
Filamentous Haemagglutinin
Pertactin
Fimbriae Types 2 and 3
Polio
Type 1
Type 2
Type 3
Haemophilus influenzae type b
PRP

Responses
PEDIACEL
Post-dose 3
N = 248

PEDIACEL
Post-dose 4
N = 220

99.2%
39.3%

-99.1%

100.0%
99.2%

-100.0%

98.7%
93.2%
87.5%
95.8%

96.7%
83.2%
86.9%
95.7%

1:8 Dilution
1:8 Dilution
1:8 Dilution

100.0%
99.2%
99.6%

99.5%
99.5%
99.5%

0.15 micrograms/mL
1.0 micrograms/mL

91.0%
63.3%

-99.1%

Criteria

0.01 IU/mL
0.1 IU/mL
0.01 IU/mL
0.1 IU/mL
seroresponse*
seroresponse†
seroresponse*
seroresponse*

* Post-dose 3
EU/mL if pre-dose 1 <4 EU/mL or post-dose 3 pre-dose 1 if pre-dose 1
EU/mL.
Four-fold rise from pre-dose 4 if pre-dose 4 <4 x 4 EU/mL or two-fold rise from pre-dose 4 4 x 4 EU/mL.
† Post-dose 3
EU/mL if pre-dose 1 <3 EU/mL or post-dose 3 pre-dose 1 if pre-dose 1
EU/mL.
Four-fold rise from pre-dose 4 if pre-dose 4 <4 x 3 EU/mL or two-fold rise from pre-dose 4 if pre-dose 4 4 x
3 EU/mL.

In a controlled clinical trial, the immunogenicity of booster vaccination with PEDIACEL
was compared to a hexavalent DTaP-IPV-Hib-Hepatitis B vaccine given at 11 to 18
months of age in toddlers who had been primed with 3 doses of DTaP-IPV-Hib-Hepatitis B
vaccine. 100% of participants receiving PEDIACEL achieved seroprotective levels for
diphtheria and tetanus (0.1 IU/mL), PRP (1.0 micrograms/mL) and all three types of
polio (1:8 dilution). The booster response rates for pertussis antigens PT, FHA, PRN and
FIM were 90.4%, 86.7%, 95.9% and 26.4%. This was the first dose containing FIM for
these participants.
In a randomized, double-blind, controlled clinical trial, the immunogenicity of PEDIACEL
was compared to another DTaP-IPV+Hib vaccine when administered to infants using the
two-dose primary immunization schedule of 3 and 5 months followed by a booster dose at
12 months. Antibody responses one month after completion of the three-dose series are
summarized below.
Table 3: Immune Response

Antigen
Diphtheria
Tetanus
Pertussis
Pertussis Toxoid
Filamentous Haemagglutinin
Pertactin
Fimbriae Types 2 and 3
Polio
Type 1
Type 2
Type 3
Haemophilus influenzae type b
PRP
* Post-dose 3
† Post-dose 3

Criteria

PEDIACEL
Post-dose 3
N = 325

0.01 IU/mL
0.1 IU/mL
0.01 IU/mL
0.1 IU/mL

98.2%
95.1%
100.0%
100.0%

seroresponse*
seroresponse†
seroresponse*
seroresponse*

1:8 Dilution
1:8 Dilution
1:8 Dilution

98.5%
99.1%
96.9%
96.3%

0.15 micrograms/mL
1.0 micrograms/mL

4 EU/mL if pre-dose 1 <4 EU/mL or post-dose 3
3 EU/mL if pre-dose 1 <3 EU/mL or post-dose 3

99.4%
99.7%
98.8%
99.1%
93.2%

pre-dose 1 if pre-dose 1
pre-dose 1 if pre-dose 1

4 EU/mL.
3 EU/mL.

Pertussis efficacy
In a clinical trial in Sweden (Sweden I Efficacy Trial), the 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 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 (≥1 day of paroxysmal cough with culture or serologic
confirmation) was 77.9%. In a controlled clinical trial in Sweden (Sweden II Trial), a
DTaP vaccine with the same formulation of pertussis antigens as PEDIACEL
demonstrated protection against pertussis with any cough.

5.2

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data

Limited pre-clinical testing of PEDIACEL and closely related products revealed no
unexpected findings and no target organ toxicity.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Phenoxyethanol
Polysorbate 80
Water for injections

6.2

Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed
with other medicinal products.

6.3

Shelf life
4 years

6.4

Special precautions for storage
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the container in the outer
carton in order to protect from light.

6.5

Nature and contents of container
0.5 mL of suspension in pre-filled syringe (type I glass) with a plunger stopper
(halobutyl elastomer), without attached needle, with a tip-cap (halobutyl
elastomer) - pack size of 1, 10 or 20.
0.5 mL of suspension in pre-filled syringe (type I glass) with a plunger stopper
(halobutyl elastomer), without attached needle, with a tip-cap (halobutyl
elastomer) and 2 separate needles - pack size of 1 or 10.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
Instructions for use

The vaccine should be used as supplied; no dilution or reconstitution is
necessary.
Inspect for extraneous particulate matter and/or discolouration before use. If these
conditions exist, the product should not be administered.

Shake the pre-filled syringe well to uniformly distribute the suspension before
administering the vaccine. The normal appearance of the vaccine is a uniform,
cloudy, white to off-white suspension, which may sediment during storage.
The needle should be pushed firmly on to the end of the pre-filled syringe and
rotated through 90 degrees.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.

7

MARKETING AUTHORISATION HOLDER

Sanofi Pasteur Europe
2 Avenue Pont Pasteur
69007 Lyon
FRANCE
Distributed in the UK by:
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS

8

MARKETING AUTHORISATION NUMBER(S)
PL 46602/0003

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
03 December 2010

10

DATE OF REVISION OF THE TEXT
19/02/2017

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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