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.
Conditions
Interventions
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 desc
Sponsors
Sanofi Pasteur Incorporated
Eligibility
Sex/Gender
All
Inclusion 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Finland, Sweden
Outcome results
None listed