Clinical Trials Register

Summary
EudraCT Number:	2005-004133-17
Sponsor's Protocol Code Number:	A5I15
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2005-11-24
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Sweden - MPA

A.2

EudraCT number

2005-004133-17

A.3

Full title of the trial

A randomised, controlled, double blind study of the immunogenicity and safety of PEDIACEL®, a combined diphtheria, tetanus, five component acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b conjugate vaccine (adsorbed) compared to Infanrix™–IPV+Hib when both vaccines are given to infants using a three dose immunisation schedule (“Nordic schedule” 3-5-12 months)

A.4.1

Sponsor's protocol code number

A5I15

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Sanofi Pasteur Incorporated
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	PEDIACEL®
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Pasteur MSD
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	PEDIACEL
D.3.2	Product code	HCPDT-IPV-PRP-T
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diphtheriae adsorbatum
D.3.9.2	Current sponsor code	D
D.3.9.3	Other descriptive name	Diphtheria Toxoid
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tetani adsorbatum
D.3.9.2	Current sponsor code	T
D.3.9.3	Other descriptive name	Tetanus Toxoid
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pertussis sine cellulis ex elementis praepartum adsorbatum (PT)
D.3.9.2	Current sponsor code	PT
D.3.9.3	Other descriptive name	Pertussis Toxoid (PT)
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pertussis sine cellulis ex elementis praepartum adsorbatum (FHA)
D.3.9.2	Current sponsor code	FHA
D.3.9.3	Other descriptive name	Filamentous Haemagglutinin (FHA)
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pertussis sine cellulis ex elementis praepartum adsorbatum (FIM)
D.3.9.2	Current sponsor code	FIM
D.3.9.3	Other descriptive name	Fimbrial Agglutinogens 2 and 3 (FIM)
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pertussis sine cellulis ex elementis praepartum adsorbatum (PRN)
D.3.9.2	Current sponsor code	PRN
D.3.9.3	Other descriptive name	Pertactin (PRN)
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Poliomyelitidis inactivatum stirpe 1
D.3.9.2	Current sponsor code	IPV
D.3.9.3	Other descriptive name	Inactivated Type 1 Poliovirus (Mahoney)
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40 to D-antigen units
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Poliomyelitidis inactivatum stirpe 2
D.3.9.2	Current sponsor code	IPV
D.3.9.3	Other descriptive name	Inactivated Type 2 Poliovirus (MEF 1)
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8 to D-antigen units
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Poliomyelitidis inactivatum stirpe 3
D.3.9.2	Current sponsor code	IPV
D.3.9.3	Other descriptive name	Inactivated Type 3 Poliovirus (Saukett)
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	32 to D-antigen units
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Haemophili stirpe b conjugatum
D.3.9.2	Current sponsor code	PRP-T
D.3.9.3	Other descriptive name	Haemophilus influenzae type b polysaccharide conjugated to 20 micrograms of Tetanus toxoid
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Infanrix™-IPV + Hib
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline AB
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Infanrix™-IPV + Hib
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diphtheriae adsorbatum
D.3.9.2	Current sponsor code	D
D.3.9.3	Other descriptive name	Diphtheria Toxoid
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tetani adsorbatum
D.3.9.2	Current sponsor code	T
D.3.9.3	Other descriptive name	Tetanus Toxoid
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pertussis sine cellulis ex elementus praepartum adsorbatum (PT)
D.3.9.2	Current sponsor code	PT
D.3.9.3	Other descriptive name	Pertussis Toxoid (PT)
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pertussis sine cellulis ex elementus praepartum adsorbatum (FHA)
D.3.9.2	Current sponsor code	FHA
D.3.9.3	Other descriptive name	Filamentous Haemagglutinin (FHA)
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pertussis sine cellulis ex elementus praepartum adsorbatum (PRN)
D.3.9.2	Current sponsor code	PRN
D.3.9.3	Other descriptive name	Pertactin
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Poliomyelitidis inactivatum stirpe 1
D.3.9.2	Current sponsor code	IPV
D.3.9.3	Other descriptive name	Inactivated Type 1 Poliovirus (Mahoney)
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40 D-antigen unit
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Poliomyelitidis inactivatum stirpe 2
D.3.9.2	Current sponsor code	IPV
D.3.9.3	Other descriptive name	Inactivated Type 2 Poliovirus (MEF 1)
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8 D-antigen unit
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Poliomyelitidis inactivatum stirpe 3
D.3.9.2	Current sponsor code	IPV
D.3.9.3	Other descriptive name	Inactivated Type 3 Poliovirus (Saukett)
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	32 D-antigen unit
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Haemophili stirpe b conjugatum
D.3.9.2	Current sponsor code	Hib
D.3.9.3	Other descriptive name	Haemophilus influenzae b polysaccharide conjugated to 30 micrograms of Tetanus Toxoid
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

PEDIACEL® is a fully liquid combination vaccine indicated for infants from 2 months of age to protect against diseases caused by 5 common pathogens: Haemophilus influenzae type b, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2 and 3.

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the immunogenicity post-dose 3 of PEDIACEL® (Group A) and Infanrix™–IPV+Hib (Group B) when administered to infants at 3, 5 and 12 months of age.

E.2.2

Secondary objectives of the trial

1. To describe the safety of PEDIACEL® and Infanrix™–IPV+Hib when administered to infants at 3, 5 and 12 months of age.
2. To compare the post-dose 3 anti-PRP GMT responses of PEDIACEL® and Infanrix™–IPV+Hib.
3. To describe the post-dose 2 and post-dose 3 antibody responses to all antigens included in the vaccines.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Infants aged 80 to 120 days inclusive on the day of inclusion.
2. Born at full term of pregnancy (>37 weeks).
3. Informed consent form signed by the parent(s) or other legal representative according to local regulations.
4. Parent(s) or legal representative able to attend all scheduled visits and to understand and comply with the study procedures (able to read and write; access to a telephone).

E.4

Principal exclusion criteria

1. Rectal temperature ≥38.0°C
2. Moderate or severe acute illness with or without fever
3. Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
4. Having received any DTaP, IPV, or Hib vaccines prior to study initiation or any vaccination in the 4 weeks preceding the first trial vaccination.
5. Planned participation in another clinical trial during the present trial period.
6. Known history of diphtheria, tetanus, pertussis, H. influenzae type b infections, poliomyelitis.
7. Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
8. Systemic hypersensitivity to any of the vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde).
9. History of a life-threatening reaction (such as encephalopathy, Hypotonic Hyporesponsive Episode, severe fever, convulsions, etc.) to the trial vaccine or a vaccine containing the same substances.
10. Blood or blood-derived products (immunoglobulins) received in the past 4 weeks.
11. Vaccination planned in the 6 weeks following any trial vaccination.
12. Known HIV seropositivity.
13. Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
14. History of seizures or progressive, evolving or unstable neurological condition.
15. Clinically significant findings on review of systems that might interfere with correct vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject (determined by the Investigator or sub-Investigator to be sufficient for exclusion).

E.5 End points

E.5.1

Primary end point(s)

1. Proportion of subjects achieving 1-month (28-42 days) post dose 3 seroprotective titres to each of the following antigens:
- Diphtheria (not less than 0.1 IU/mL)
- Tetanus (not less than 0.1 IU/mL)
- Hib (not less than 1.0 µg/mL)
- Polio 1, 2, and 3 (not less than 8 reciprocal dilution)
2. Proportion of subjects achieving 1 month (28-42 days) post-dose 3 seroresponse (defined as seropositivity) for each of the following pertussis antigens:·
PT
FHA
PRN
FIM
Pertussis seroresponse is defined as detectable (above lower limit of quantitation [LLOQ]) antibodies at post-dose 3 in subjects with undetectable antibodies pre-vaccination, or at least maintenance of pre-vaccination antibody concentration in subjects who were initially seropositive.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last visit of the last subject

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Infants and toddlers

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

800

F.4.2.2

In the whole clinical trial

800

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Not applicable

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2006-01-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2005-12-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2007-05-28

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