Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand

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 DTacP-IPV// PRP T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.

Conditions
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Diphtheria, Tetanus, Poliomyelitis, Haemophilus Infections, Pertussis

Intervention / Treatment
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* Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 53 to 70 days inclusive on the day of inclusion 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 corticosteroid 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. Mother known as seropositive to HIV or hepatitis B Any vaccination in the 5 weeks preceding the first trial vaccination (except Bacille Calmette-Guerin [BCG]) History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or hepatitis B (confirmed either clinically, serologically or microbiologically). Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae 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: 2 Months
Maximum Age: 2 Months

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: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac<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 |
| --- | --- | --- |
| Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP T combined vaccine |  | 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, Haemophilus influenzae type b, acellular