Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months

Study Overview
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Brief Summary
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As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet the requirements for registration of the product in People's Republic of China.

Conditions
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Diphtheria, Tetanus, Haemophilus Influenzae Type b, Pertussis, Poliomyelitis

Intervention / Treatment
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* Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
* Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
* Biological: Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Aged 2 months (60 to 74 days) inclusive on the day of inclusion Born at full term pregnancy (³36 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 trial inclusion 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 performed or planned in the 4 weeks preceding the first trial visit (except BCG and Hepatitis B, which can not be given within 8 days before the first study visit) Vaccination planned in the 4 weeks following any trial vaccination (except BCG and Hepatitis B, which can not be given within 8 days before or after the study vaccine(s) administration) History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically) Clinical or serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection 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 (axillary temperature ≥ 37.1°C) or acute illness on the day of inclusion

Ages Eligible for Study
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Minimum Age: 60 Days
Maximum Age: 74 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>DTacP IPV// PRP T combined vaccine at 2, 3 and 4 months of age, and a booster dose at 18-20 months of age. | Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib<br>* 0.5 mL, IM<br>* Other names: PENTAXIM™;|
| Experimental: 2<br>DTacP-IPV// PRP T combined vaccine at 3, 4 and 5 months of age and a booster dose at 18-20 months of age. | Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib<br>* 0.5 mL, IM<br>* Other names: PENTAXIM™;|
| Active Comparator: 3<br>Control vaccines at 3, 4 and 5 months of age and a booster dose at 18-20 months of age | Biological: Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed<br>* 0.5 mL, IM<br>* Other names: DTacP, Act-HIB™ and IMOVAX Polio™;|

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 DTacP-IPV//PRP T combined vaccine |  | 1 Month post-dose 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the safety of DTacP-IPV//PRP T combined vaccine |  | 19 months post-dose 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diphteria, Tetanus, Haemophilus influenzae type b, Poliomyelitis, Pertussis