Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

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

Primary Objective:

• To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series.

Secondary Objectives:

• To describe in each group the immunogenicity parameters one month after the three-dose primary series.
• To describe safety profile after each vaccination in both groups.

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.