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

September 23, 2016 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1090
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
  • Germany
    • Baden-Wuerttemberg
      • Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
        • GSK Investigational Site
      • Boennigheim, Baden-Wuerttemberg, Germany, 74357
        • GSK Investigational Site
      • Ehingen, Baden-Wuerttemberg, Germany, 89584
        • GSK Investigational Site
      • Kehl, Baden-Wuerttemberg, Germany, 77694
        • GSK Investigational Site
      • Kirchzarten, Baden-Wuerttemberg, Germany, 79199
        • GSK Investigational Site
      • Ludwigsburg, Baden-Wuerttemberg, Germany, 71634
        • GSK Investigational Site
      • Marbach, Baden-Wuerttemberg, Germany, 71672
        • GSK Investigational Site
      • Oberkirch, Baden-Wuerttemberg, Germany, 77704
        • GSK Investigational Site
      • Offenburg, Baden-Wuerttemberg, Germany, 77654
        • GSK Investigational Site
      • Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
        • GSK Investigational Site
      • Stuttgart, Baden-Wuerttemberg, Germany, 70469
        • GSK Investigational Site
      • Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
        • GSK Investigational Site
      • Tettnang, Baden-Wuerttemberg, Germany, 88069
        • GSK Investigational Site
    • Bayern
      • Bindlach, Bayern, Germany, 95463
        • GSK Investigational Site
      • Cham, Bayern, Germany, 93413
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81735
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81241
        • GSK Investigational Site
      • Olching, Bayern, Germany, 82140
        • GSK Investigational Site
      • Weilheim, Bayern, Germany, 82362
        • GSK Investigational Site
      • Werneck, Bayern, Germany, 97440
        • GSK Investigational Site
    • Hessen
      • Eschwege, Hessen, Germany, 37269
        • GSK Investigational Site
      • Fulda, Hessen, Germany, 36037
        • GSK Investigational Site
      • Niedernhausen, Hessen, Germany, 65527
        • GSK Investigational Site
    • Niedersachsen
      • Wolfenbuettel, Niedersachsen, Germany, 38302
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44866
        • GSK Investigational Site
      • Detmold, Nordrhein-Westfalen, Germany, 32756
        • GSK Investigational Site
      • Dortmund, Nordrhein-Westfalen, Germany, 44329
        • GSK Investigational Site
      • Espelkamp, Nordrhein-Westfalen, Germany, 32339
        • GSK Investigational Site
      • Herford, Nordrhein-Westfalen, Germany, 32049
        • GSK Investigational Site
      • Hille, Nordrhein-Westfalen, Germany, 32479
        • GSK Investigational Site
      • Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
        • GSK Investigational Site
      • Krefeld, Nordrhein-Westfalen, Germany, 47798
        • GSK Investigational Site
      • Loehne, Nordrhein-Westfalen, Germany, 32584
        • GSK Investigational Site
      • Minden, Nordrhein-Westfalen, Germany, 32427
        • GSK Investigational Site
      • Muenster, Nordrhein-Westfalen, Germany, 48163
        • GSK Investigational Site
      • Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
        • GSK Investigational Site
      • Viersen, Nordrhein-Westfalen, Germany, 41749
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Frankenthal, Rheinland-Pfalz, Germany, 67227
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germany, 54290
        • GSK Investigational Site
    • Schleswig-Holstein
      • Brunsbuettel, Schleswig-Holstein, Germany, 25541
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24937
        • GSK Investigational Site
      • Gluecksburg, Schleswig-Holstein, Germany, 24960
        • GSK Investigational Site
      • Husum, Schleswig-Holstein, Germany, 25813
        • GSK Investigational Site
      • Neumuenster, Schleswig-Holstein, Germany, 24534
        • GSK Investigational Site
    • Thueringen
      • Neuhaus am Rennweg, Thueringen, Germany, 98724
        • GSK Investigational Site
  • Netherlands
      • Rotterdam, Netherlands, 3015 GE
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 months to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Antibody levels after vaccination

Secondary Outcome Measures

Outcome Measure
Safety of the study vaccines

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion (ACTUAL)

June 1, 2006

Study Registration Dates

First Submitted

August 4, 2005

First Submitted That Met QC Criteria

August 4, 2005

First Posted (ESTIMATE)

August 5, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 26, 2016

Last Update Submitted That Met QC Criteria

September 23, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103388

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Study Protocol
    Information identifier: 103388
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Clinical Study Report
    Information identifier: 103388
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistical Analysis Plan
    Information identifier: 103388
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: 103388
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103388 are summarised with followup study 104690 on the GSK Clinical Study Register.
  5. Informed Consent Form
    Information identifier: 103388
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Dataset Specification
    Information identifier: 103388
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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