Status:

COMPLETED

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

Lead Sponsor:

GlaxoSmithKline

Conditions:

Mumps

Varicella

Eligibility:

All Genders

11-21 years

Phase:

PHASE3

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...

Detailed Description

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2005

Trial Type :

INTERVENTIONAL

End Date :

November 1 2005

Estimated Enrollment :

944 Patients enrolled

Trial Details

Trial ID

NCT00127023

Start Date

May 1 2005

End Date

November 1 2005

Last Update

September 21 2016

Active Locations (85)

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Page 1 of 22 (85 locations)

1

GSK Investigational Site

Bad Saulgau, Baden-Wurttemberg, Germany, 88348

2

GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, Germany, 74357

3

GSK Investigational Site

Bretten, Baden-Wurttemberg, Germany, 75015

4

GSK Investigational Site

Ehingen, Baden-Wurttemberg, Germany, 89584