Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine

September 14, 2016 updated by: GlaxoSmithKline

Follow-up to Evaluate the the Immunogenicity & Safety of GSK Biologicals' MMRV Vaccine Given as a Two-dose Schedule in the Second Year of Life, as Compared to Separate Administration of GSK Biologicals' Priorix® & Varilrix®.

Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany & Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 & 3). No new subjects will be enrolled in these follow-up phases of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

398

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

  • Austria
      • Klagenfurt, Austria, A-9020
        • GSK Investigational Site
      • Neufeld/Leitha, Austria, A 2491
        • GSK Investigational Site
      • Salzburg, Austria, A-5020
        • GSK Investigational Site
      • Villach, Austria, A-9500
        • GSK Investigational Site
  • Germany
      • Hamburg, Germany, 22089
        • GSK Investigational Site
    • Bayern
      • Bindlach, Bayern, Germany, 95463
        • GSK Investigational Site
      • Marktredwitz, Bayern, Germany, 95615
        • GSK Investigational Site
      • Olching, Bayern, Germany, 82140
        • GSK Investigational Site
      • Tegernsee, Bayern, Germany, 83684
        • GSK Investigational Site
      • Tutzing, Bayern, Germany, 82327
        • GSK Investigational Site
    • Hessen
      • Bad Camberg, Hessen, Germany, 65520
        • GSK Investigational Site
      • Fulda, Hessen, Germany, 36037
        • GSK Investigational Site
      • Hochheim, Hessen, Germany, 65239
        • GSK Investigational Site
      • Marburg/Lahn, Hessen, Germany, 35039
        • GSK Investigational Site
      • Nidderau, Hessen, Germany, 61130
        • GSK Investigational Site
      • Ruesselsheim, Hessen, Germany, 65428
        • GSK Investigational Site
      • Wiesbaden, Hessen, Germany, 65205
        • GSK Investigational Site
    • Niedersachsen
      • Salzgitter, Niedersachsen, Germany, 38226
        • GSK Investigational Site
      • Wolfenbuettel, Niedersachsen, Germany, 38302
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • GSK Investigational Site
      • Detmold, Nordrhein-Westfalen, Germany, 32756
        • GSK Investigational Site
      • Guetersloh, Nordrhein-Westfalen, Germany, 33332
        • GSK Investigational Site
      • Kirchlengern, Nordrhein-Westfalen, Germany, 32278
        • GSK Investigational Site
      • Loehne, Nordrhein-Westfalen, Germany, 32584
        • GSK Investigational Site
      • Muenster, Nordrhein-Westfalen, Germany, 48159
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
        • GSK Investigational Site
      • Bad Sobernheim, Rheinland-Pfalz, Germany, 55566
        • GSK Investigational Site
      • Frankenthal, Rheinland-Pfalz, Germany, 67227
        • GSK Investigational Site
      • Gau-Algesheim, Rheinland-Pfalz, Germany, 55435
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Germany, 55116
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
      • Schoeneberg - Kuebelberg, Rheinland-Pfalz, Germany, 66901
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germany, 54290
        • GSK Investigational Site
      • Worms, Rheinland-Pfalz, Germany, 67547
        • GSK Investigational Site
    • Schleswig-Holstein
      • Altenholz, Schleswig-Holstein, Germany, 24161
        • GSK Investigational Site
      • Bredstedt, Schleswig-Holstein, Germany, 25821
        • GSK Investigational Site
      • Brunsbuettel, Schleswig-Holstein, Germany, 25541
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24937
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24943
        • GSK Investigational Site
      • Husum, Schleswig-Holstein, Germany, 25813
        • GSK Investigational Site
      • Neumuenster, Schleswig-Holstein, Germany, 24534
        • 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

4 months to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent from the parents/guardians of the child before participating in the long-term follow-up.
  • Subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of MMRV combined vaccine, or two doses of Priorix vaccine and one dose of Varilrix vaccine as separate injections in the primary vaccination study.
  • Subjects were aged between 12 to 18 months of age at the time of the first vaccination in the primary study.

Exclusion Criteria:

  • Subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.

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 Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year
Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination

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.

General Publications

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

July 1, 2004

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

December 1, 2006

First Submitted That Met QC Criteria

December 1, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208136/039
  • 208136/040
  • 208136/041

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. Clinical Study Report
    Information identifier: 208136/039
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: 208136/039
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: 208136/039
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: 208136/039
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Study Protocol
    Information identifier: 208136/039
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informed Consent Form
    Information identifier: 208136/039
    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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