drugset / Trial / NCT01204658

Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants

NCT01204658

Phase 2 Completed 576 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindPrevention

Summary

This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.

Timeline

Start
2010-09-27
Primary completion
2011-11-03
Completion
2012-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK2189242A Vaccine Intramuscular
Comparator Prevnar 13 Vaccine Intramuscular
Comparator Synflorix Vaccine Intramuscular
Background Infanrix hexa Vaccine Intramuscular