Hepatitis B Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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