Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™

October 6, 2016 updated by: GlaxoSmithKline

Comparative Study Evaluating the Immunogenicity and Safety of MeMuRu-OKA Vaccine and Measles-mumps-rubella Vaccine (Priorix™) Co-administered With Varicella Vaccine (Varilrix™) in Children Primed With Measles-mumps-rubella Vaccine

As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

446

Phase

  • Phase 2

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

  • France
      • Ancenis, France, 44150
        • GSK Investigational Site
      • Boulogne, France, 92100
        • GSK Investigational Site
      • Dax, France, 40100
        • GSK Investigational Site
      • Draguignan, France, 83300
        • GSK Investigational Site
      • Essey les Nancy, France, 54270
        • GSK Investigational Site
      • Laon, France, 02000
        • GSK Investigational Site
      • Le Havre, France, 76600
        • GSK Investigational Site
      • Lingolsheim, France, 67380
        • GSK Investigational Site
      • Lyon, France, 69437
        • GSK Investigational Site
      • Nice, France, 06300
        • GSK Investigational Site
      • Paris, France, 75019
        • GSK Investigational Site
      • Villeneuve les Avignons, France, 30400
        • GSK Investigational Site
  • Germany
    • Baden-Wuerttemberg
      • Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
        • GSK Investigational Site
      • Boennigheim, Baden-Wuerttemberg, Germany, 74357
        • GSK Investigational Site
      • Kehl, Baden-Wuerttemberg, Germany, 77694
        • GSK Investigational Site
      • Kirchzarten, Baden-Wuerttemberg, Germany, 79199
        • GSK Investigational Site
      • Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
        • GSK Investigational Site
      • Schwieberdingen, Baden-Wuerttemberg, Germany, 71701
        • GSK Investigational Site
      • Stuttgart, Baden-Wuerttemberg, Germany, 70469
        • 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
      • Kempten, Bayern, Germany, 87435
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81241
        • GSK Investigational Site
      • Olching, Bayern, Germany, 82140
        • GSK Investigational Site
      • Werneck, Bayern, Germany, 97440
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
        • GSK Investigational Site
      • Detmold, Nordrhein-Westfalen, Germany, 32756
        • GSK Investigational Site
      • Herford, Nordrhein-Westfalen, Germany, 32049
        • GSK Investigational Site
      • Krefeld, Nordrhein-Westfalen, Germany, 47798
        • GSK Investigational Site
      • Loehne, Nordrhein-Westfalen, Germany, 32584
        • GSK Investigational Site
    • Schleswig-Holstein
      • Flensburg, Schleswig-Holstein, Germany, 24937
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24943
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24944
        • GSK Investigational Site
      • Neumuenster, Schleswig-Holstein, Germany, 24534
        • GSK Investigational Site
  • Italy
    • Liguria
      • Genova, Liguria, Italy, 16132
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • GSK Investigational Site
    • Sardegna
      • Cagliari, Sardegna, Italy, 09127
        • GSK Investigational Site
      • Sassari, Sardegna, Italy, 07100
        • 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

1 year to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children must be healthy to participate

Exclusion Criteria:

  • Immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
  • Children must have received one dose (but not more) of MMR at least 6 weeks before entering the study.
  • They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days.
  • Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol, 30 days before until 56 days after vaccination.
  • Children must not have been vaccinated against varicella.
  • They must not have had measles, mumps, rubella or varicella, or have been exposed to those diseases within 30 days prior to study start.
  • New-born infants (< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child.

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
Varicella seroconversion and MMR titres at 42-56 days after first vaccination

Secondary Outcome Measures

Outcome Measure
Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)

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

March 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

July 17, 2006

First Submitted That Met QC Criteria

July 17, 2006

First Posted (Estimate)

July 18, 2006

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105908

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: 105908
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: 105908
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: 105908
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: 105908
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: 105908
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistical Analysis Plan
    Information identifier: 105908
    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.

Clinical Trials on Measles

Clinical Trials on MMR, Varicella vacc (control)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe