drugset / Trial / NCT00871117

Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years

NCT00871117

Phase 3 Completed 478 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of the study is to evaluate the immunogenicity and safety of Kinrix when co-administered with varicella (Varivax® \[varicella virus vaccine live\], Merck and Company) and (measles mumps rubella) MMR vaccines, compared to Kinrix co-administered with MMR vaccine alone. Both Kinrix and the second dose of Varivax are indicated in children 4-6 years of age, and there is great potential for the vaccines to be given concurrently. The aim of this trial is to demonstrate that co-administered Varivax does not negatively affect the immunogenicity or reactogenicity of Kinrix.

Timeline

Start
2009-03-31
Primary completion
2010-01-15
Completion
2010-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Kinrix Vaccine Intramuscular
Subject Varivax Vaccine Subcutaneous
Background MMRII Vaccine Subcutaneous

Indications