drugset / Trial / NCT00320463

Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants

NCT00320463 ↗

Phase 3 Completed 415 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindPrevention

Summary

In this study, infants will be randomly allocated into three groups: * one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation) * the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation) * the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.

Timeline

Start
2006-04
Primary completion
—
Completion
2007-01

Drugs

EvaluationDrugModalityDoseRoute
Subject DTPa-HBV-IPV/Hib vaccine Vaccine — —