Blinded, Randomized Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Measles-mumps-rubella-varicella Candidate Vaccine Given to Healthy Children During the Second Year of Life

GlaxoSmithKline1 site in 1 countryNovember 2005

ConditionsMeasles Rubella Mumps Varicella

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Measles
Sponsor: GlaxoSmithKline
Locations: 1
Primary Endpoint: Antibody levels after vaccination
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.

Detailed Description

This study included an active control group who received the licensed Priorix (measles, mumps, rubella \[MMR\] vaccine).

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

June 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination.

Exclusion Criteria

•History of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial
•Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination