drugset / Trial / NCT00316680

Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.

NCT00316680

Phase 3 Terminated 288 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindPrevention

Summary

A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b. A vaccine from Commonwealth Serum Laboratories (diphtheria, tetanus, pertussis) which is co-administered with Haemophilus influenzae type b vaccine will also be used as a comparator. Reactogenicity and safety of all vaccines will be assessed as well.

Timeline

Start
2006-03
Primary completion
Completion
2006-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Hepatitis B Vaccine