drugset / Trial / NCT01096056

Trial to Evaluate the Safety and the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Healthy Children

NCT01096056

Phase 1 Completed 40 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in healthy children 6 to 35 months of age. This Protocol Posting has been updated following Amendment 1 of the Protocol, Jun 2010. The impacted sections are study design, outcome measures, intervention sections and number of subjects.

Timeline

Start
2010-04-05
Primary completion
2010-12-13
Completion
2010-12-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Influenza vaccine GSK2186877A formulation 1 Vaccine Intramuscular
Subject Influenza vaccine GSK2186877A formulation 2 Vaccine Intramuscular
Background Influenza Virus Vaccine Vaccine Intramuscular

Indications