Phase-II Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants

Date de début de l'étude : 1 octobre 2004

Inclusion Criteria : * Infant of either gender, aged 50 to 70 days inclusive * Mother is negative for HBsAg * Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg * Written informed consent form signed by at least one parent or by another legal representative and an independent witness * Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial. Exclusion Criteria : * Axillary temperature ≥37.1°C on the day of inclusion * Current or planned enrolment in another clinical trial during the clinical trial period * Known mother's history of Human Immunodeficiency Virus (HIV) infection * Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days) * Receipt of blood-derived products since birth * Acute symptoms or severe chronic illness (e.g. cardiac, renal insufficiency, diabetes, auto immune disorders, congenital defect) that may interfere with conduct or completion of trial * Occurrence of seizures since birth * Hypersensitivity to any of the vaccine components * Coagulopathy contraindicating intramuscular injection * History of (documented) clinical or serological/microbiological confirmed infection due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b (Hib) or hepatitis B (HB) diseases * History of vaccination against pertussis, tetanus, diphtheria, polio, Hib or HB infections * Vaccination within the last 4 weeks.