Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine

Sanofi Pasteur, a Sanofi Company379 enrolled

Overview

The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP\~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule. The primary objective is: * To demonstrate that the pentavalent DTaP-HB-PRP\~T combined vaccine does not induce a lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age. The secondary objectives are: * To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6, 10, and 14 weeks of age; and * To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

379

Conditions

Diphtheria Tetanus Pertussis Hepatitis B

Eligibility

Sex: ALLMin age: 42 DaysMax age: 50 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Six week old infants (42 to 50 days old) on the day of inclusion; of either gender. * Mother tested as seronegative for hepatitis B surface antigen (HBsAg) between 28 weeks of pregnancy and up to 4 days after delivery * Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg * Informed consent form signed by one parent or other legal representative if appropriate (independent witness is mandatory if parent is illiterate) * Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: * Participation in another clinical trial in the 4 weeks preceding the first trial vaccination * Planned participation in another clinical trial during the present trial period * Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid therapy. * Chronic illness at a stage that could interfere with the conduct or completion of the trial * Blood or blood-derived products received since birth * HB vaccination since birth * Any vaccination in the four weeks preceding the first trial vaccination * Any planned vaccination (except trial vaccines and bacillus Calmette-Guerin (BCG) during the trial * Documented history of pertussis, tetanus (T), diphtheria (D), polio, or Haemophilus influenzae type b (Hib) infection(s) (confirmed either clinically, serologically, or microbiologically) * Known personal or maternal history of HIV, HBsAg or hepatitis C seropositivity * Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination * History of seizures * Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.

Outcomes

Primary Outcomes

Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV

Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination.