Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV

Study Overview
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Brief Summary
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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 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/ vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France).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. Safety: To assess and describe the safety of the study vaccines after each dose.

Conditions
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Pertussis, Diphtheria, Poliomyelitis, Tetanus

Intervention / Treatment
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* Biological: DTaP-IPV combined vaccine
* Biological: DTaP vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 56 Days
Maximum Age: 70 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: DTaP-IPV combined vaccine<br>* 0.5 mL, IM<br>* Other names: TETRAXIM™: Diphtheria, Tetanus, Polio, Acellular Pertussis;|
| Active Comparator: 2<br> | Biological: DTaP vaccine<br>* 0.5 mL, IM<br>* Other names: DTaP vaccine (CJ purified PDT vaccine ™);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diphteria;, Tetanus;, Pertussis;, Poliomyelitis;, acellular