Hepatitis B Clinical Trial
Official title:
Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to CombAct-HIB® Concomitantly Administered With Engerix B® Paediatric and OPV at 6, 10, and 14 Weeks of Age in South African Infants
The purpose of this study is to document the immunological response to the investigational
hexavalent vaccine at the 6, 10, and 14 weeks schedule
The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined
vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric
and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B
(HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6,
10, and 14 weeks) with no HB vaccination at birth.
The secondary Objectives are:
To describe the safety in terms of any adverse events in the first 28 days after each
injection and any serious adverse events during the entire trial.
To describe Immunogenicity after the primary series and prior to and after a booster
vaccination.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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