drugset / Trial / NCT01449812

Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine

NCT01449812

Phase 3 Completed 831 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423).

Timeline

Start
2011-10-01
Primary completion
2012-01-16
Completion
2012-01-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Infanrix+Hib™ Vaccine Intramuscular
Subject Poliorix™ Vaccine Intramuscular