Diphtheria, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Diphteria;, Tetanus;, Pertussis;, Poliomyelitis;, acellular
Brief summary
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months of age compared to commercially available vaccines in order to meet the requirements for registration of the product in South Korea. Primary objective To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP (CJ purified PDT vaccine ™) and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines, one month after the three-dose primary vaccination. Secondary objectives 1. Immunogenicity: To assess the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion / vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France). To assess and describe the immunogenicity of the study vaccines in both groups. 2. Safety: To assess and describe the safety of the study vaccines after each dose.
Interventions
BIOLOGICALDTaP-IPV combined vaccine
0.5 mL, IM
BIOLOGICALDTaP vaccine
0.5 mL, IM
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
56 Days to 70 Days
Healthy volunteers
Yes
Inclusion criteria
* Aged 56 to 70 days inclusive on the day of inclusion * Born at full term pregnancy (\>37 weeks) with a birth weight ≥ 2.5 kg * Informed consent form signed by the parent(s) or other legal representative * Able to attend all scheduled visits and to comply with all trial procedures
Exclusion criteria
* Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination * Planned participation in another clinical trial during the present trial period. * Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy. * Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances. * Chronic illness at a stage that could interfere with trial conduct or completion. * Blood or blood-derived products received in the past or planned administration during the trial (including immunoglobulins). * Any vaccination in the 3 weeks preceding the first trial vaccination. * History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically). * Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases with the trial vaccine or another vaccine. * Thrombocytopenia or a bleeding disorders contraindicating intramuscular vaccination * History of major neurological diseases or seizures. * Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) on the day of inclusion. * Known family history of congenital or genetic immuno-deficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To provide information concerning the immunogenicity of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines. | 1 month post-vaccination |
Countries
South Korea
Outcome results
None listed