Immunogenicity and Safety of Pentaxim in South African Infants

Study Overview
=================
Brief Summary
-----------------
The present clinical study will assess the immunogenicity and reactogenicity 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 in order to meet the requirements for application for the use of the product in the Expanded Program on Immunization (EPI) in South Africa.

Conditions
-----------------
Diphtheria, Tetanus, Haemophilus Infections, Pertussis, Poliomyelitis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged < 24 hours on the day of inclusion Exclusion Criteria: At visit 01 (screening) Illness at a stage that could interfere with trial conduct or completion. Any vaccination preceding the trial participation (except Bacille Calmette-Guerin [BCG]) Acute illness on the day of screening. At visit 01 and visit 02 (screening and first study vaccination). Planned participation in another clinical trial during the present trial period Blood or blood-derived products received since birth. Mother known as seropositive to HIV or hepatitis B. Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination History of/current seizures at visit 02 (first study vaccination) Participation in another clinical trial preceding the first trial vaccination 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. Any vaccination preceding the first trial vaccination (except BCG) History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection (confirmed either clinically, serologically or microbiologically). Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection with the trial vaccine or another vaccine. Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of first vaccination

Ages Eligible for Study
-----------------
Minimum Age: 24 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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<br>* 0.5 mL, Im<br>* Other names: PENTAXIM™;|

What is the study measuring?
-----------------
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-vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diphteria, tetanus, haemophilus influenzae type b, poliomyelitis, pertussis