drugset / Trial / NCT00627458

Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine

NCT00627458

Phase 2 Completed 403 enrolled GlaxoSmithKline
Non-randomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).

Timeline

Start
2008-02-01
Primary completion
2008-08-18
Completion
2008-08-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Infanrix hexa Vaccine Intramuscular