Immunogenicity and Safety of Pentaxim™ in an Indian Population

Study Overview
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Brief Summary
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The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life. Safety: This study will describe the safety after each dose of the primary series of the study's combined vaccine (Pentaxim™).

Official Title
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Immunogenicity and Safety of the Sanofi Pasteur DTacP-IPV//PRP T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants in India.

Conditions
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Diphtheria, Tetanus, Polio, Pertussis, Haemophilus Infections

Intervention / Treatment
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* Biological: Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 42 to 56 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. Any vaccination preceding the trial vaccination (except BCG and hepatitis B) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Haemophilus influenza type b (confirmed either clinically, serologically or microbiologically). Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenza type b infection with the trial vaccine or another vaccine. Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination History of/current seizures Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion.

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 56 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine<br>* 0.5 mL, IM<br>* Other names: PENTAXIM™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the safety of DTacP-IPV//PRP T combined vaccine |  | 19 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diphteria, Tetanus, Polio, Acellular Pertussis, Hib, Haemophilus influenzae type B