drugset / Trial / NCT01035749

Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years

NCT01035749

Phase 2 Completed 310 enrolled GlaxoSmithKline
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine.

Timeline

Start
2010-02-01
Primary completion
2010-09-27
Completion
2011-05-10

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK2340273A Vaccine Intramuscular
Subject GSK2340274A Vaccine Intramuscular

Indications