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Diphtheria
+4

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

Sponsored by Sanofi Pasteur, a Sanofi Company

About this trial

Last updated 11 years ago

Study ID

A3L02

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
50 to 70 Years
All
All

Trial Timing

Ended 18 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.