Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes

October 9, 2008 updated by: GlaxoSmithKline

Open, Multicenter, Randomised, Controlled Phase IIIb Study Evaluating the Immunogenicity and Safety of Subcutaneous Versus Alternative Administration Route of Combined MeMuRu-OKA Vaccine to Healthy Children Aged 11 to 21 Months.

This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Biological: MeMuRu-OKA (study vaccine)

Study Type

Interventional

Enrollment

330

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

Germany
- Baden-Wuerttemberg
  - Boennigheim, Baden-Wuerttemberg, Germany, 74357
    - GSK Investigational Site
  - Bretten, Baden-Wuerttemberg, Germany, 75015
    - GSK Investigational Site
  - Ettenheim, Baden-Wuerttemberg, Germany, 77955
    - GSK Investigational Site
  - Karlsruhe, Baden-Wuerttemberg, Germany, 76189
    - GSK Investigational Site
  - Kehl, Baden-Wuerttemberg, Germany, 77694
    - GSK Investigational Site
  - Mannheim, Baden-Wuerttemberg, Germany, 68167
    - 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
- Hessen
  - Eschwege, Hessen, Germany, 37269
    - GSK Investigational Site
  - Giessen, Hessen, Germany, 35390
    - GSK Investigational Site
- Rheinland-Pfalz
  - Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
    - GSK Investigational Site
  - Frankenthal, Rheinland-Pfalz, Germany, 67227
    - GSK Investigational Site
  - Mainz, Rheinland-Pfalz, Germany, 55131
    - GSK Investigational Site
  - Mainz, Rheinland-Pfalz, Germany, 55127
    - GSK Investigational Site
  - Trier, Rheinland-Pfalz, Germany, 54290
    - GSK Investigational Site
  - Trier, Rheinland-Pfalz, Germany, 54294
    - GSK Investigational Site
  - Worms, Rheinland-Pfalz, Germany, 67547
    - 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:

Children must be healthy and have a birth weight > 2000 g to participate

Exclusion Criteria:

confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study.
Children must have received one dose (but not more) of MMR and of varicella 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 within 30 days before vaccination.
Children must not have had measles, mumps, rubella or varicella/zoster, 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
Seroconversion rates after vaccination

Secondary Outcome Measures

Outcome Measure
Antibody titres; 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

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

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

July 12, 2006

First Submitted That Met QC Criteria

July 12, 2006

First Posted (Estimate)

July 13, 2006

Study Record Updates

Last Update Posted (Estimate)

October 13, 2008

Last Update Submitted That Met QC Criteria

October 9, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

106670

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.