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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Poliomyelitis

Haemophilus Influenzae Type b

Diphtheria

Pertussis

Tetanus

Treatments

Biological: DTaP-IPV-HB-PRP~T

Biological: DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine

Study type

Interventional

Funder types

Industry

Identifiers

A3L02

Details and patient eligibility

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.

Enrollment

624 patients

Sex

All

Ages

50 to 70 days old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.