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)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-004133-17-FI
• Date of registration: 18/10/2005
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur Incorporated
• Public title: 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)
• Scientific title: 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)
• Date of first enrolment: 19/01/2006
• Target sample size: 800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004133-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Finland, Sweden

Key inclusion & exclusion criteria

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).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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.

Intervention(s)

Trade Name: PEDICAEL®
Product Name: PEDIACEL®
Product Code: HCPDT-IPV-PRP-T
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Diphtheriae adsorbatum
Current Sponsor code: D
Other descriptive name: Diphtheria Toxoid
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 30-
INN or Proposed INN: Tetani adsorbatum
Current Sponsor code: T
Other descriptive name: Tetanus Toxoid
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 40-
INN or Proposed INN: Pertussis sine cellulis ex elementis praepartum adsorbatum (PT)
Current Sponsor code: PT
Other descriptive name: Pertussis Toxoid (PT)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: Pertussis sine cellulis ex elementis praepartum adsorbatum (FHA)
Current Sponsor code: FHA
Other descriptive name: Filamentous Haemagglutinin (FHA)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: Pertussis sine cellulis ex elementis praepartum adsorbatum (FIM)
Current Sponsor code: FIM
Other descriptive name: Fimbrial Agglutinogens 2 and 3 (FIM)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Pertussis sine cellulis ex elementis praepartum adsorbatum (PRN)
Current Sponsor code: PRN
Other descriptive name: Pertactin (PRN)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 3-
INN or Proposed INN: Poliomyelitidis inactivatum stirpe 1
Current Sponsor code: IPV
Other descriptive name: Inactivated Type 1 Poliovirus (Mahoney)
Concentration type: equal
Concentration number: 40-D-antigen units
INN or Proposed INN: Poliomyelitidis inactivatum stirpe 2
Current Sponsor code: IPV
Other descriptive name: Inactivated Type 2 Poliovirus (MEF 1)
Concentration type: equal
Concentration number: 8-D-antigen units
INN or Proposed INN: Poliomy

Primary Outcome(s)

Main Objective: 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.

Secondary Objective: 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.

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.

Secondary ID(s)

A5I15