Large Scale Safety and Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix HepB/Hib™, Both Given Concomitantly With OPV at 6, 10, and 14 Weeks of Age in Healthy Filipino Infants

NCT00348881 Phase 3 COMPLETED Results posted

This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP\~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 3
Status	COMPLETED
Enrolment	2133
Start date	2006-06
Completion	2008-06

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Influenza

Interventions

• DTaP-HB-PRP~T combined vaccine
• Tritanrix-HepB/Hib™ vaccine
• Oral poliomyelitis vaccine (OPV)

Primary outcomes

• Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV — 1 month post third vaccination
  Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.
• Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. — Day 0 to Day 7 post-vaccination
  Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.

Countries

Philippines