Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix-HepB/Hib™, Both Given Concomitantly With the Oral Polio Vaccine at 6, 10, and 14 Weeks of Age in Healthy Infants in the Philippines

NCT00343889 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 3
Status	COMPLETED
Enrolment	379
Start date	2006-08
Completion	2008-04

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Haemophilus Infections

Interventions

• DTaP-HB-PRP~T vaccine + OPV
• Tritanrix-HepB/Hib™ + OPV vaccine
• Oral Polio Vaccine

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 — 1 month post third vaccination
  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.

Countries

Philippines