Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases

Phase 3

Completed

• Conditions: Varicella; Mumps; Rubella; Measles

• Registration Number: NCT00127023
• Lead Sponsor: GlaxoSmithKline

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

Separate injections of the licensed Priorix (MMR vaccine) and Varilrix (chickenpox vaccine) serve as control.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-08-04
• Study First Submitted QC: 2005-08-04
• Study First Posted: 2005-08-05
• Study Completion: 2005-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 944

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Antibody levels after vaccination.

Secondary Outcome Measures

Name	Time	Method
Safety of the study vaccines.

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Hamburg, Germany