drugset / Trial / NCT00871338

Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants

NCT00871338

Phase 2 Completed 284 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.

Timeline

Start
2009-06-24
Primary completion
2010-03-31
Completion
2010-12-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Hepatitis B Vaccine Intramuscular
Comparator Menjugate Vaccine Intramuscular
Comparator Pediacel® Vaccine Intramuscular
Background Menitorix Vaccine Intramuscular
Background Prevnar 13 Vaccine Intramuscular