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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00127023
First received: August 4, 2005
Last updated: November 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Rubella
Mumps
Measles
Chickenpox
 Biological: Measles, Mumps, Rubella and Chickenpox (live vaccine)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Blinded, Randomised, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Combined Measles-mumps-rubella-varicella Candidate Vaccine Given to Healthy Children in Their Second Year of Life

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Antibody levels after vaccination.

Secondary Outcome Measures:
  • Safety of the study vaccines.

Estimated Enrollment: 944
Study Start Date: May 2005
Intervention Details:
    Biological: Measles, Mumps, Rubella and Chickenpox (live vaccine)
    Other Names:
    • Measles
    • Mumps
    • Rubella and Chickenpox (live vaccine)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   11 Months to 21 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127023

  Show 76 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Sohita D et al. (2008) Live Attenuated Measles, Mumps, Rubella, and Varicella Zoster Virus Vaccine (Priorix-Tetra). Pediatric Drugs. 10 (5):337-347.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00127023     History of Changes
Other Study ID Numbers: 104389
Study First Received: August 4, 2005
Last Updated: November 1, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Prophylaxis measles, mumps, rubella and chickenpox

Additional relevant MeSH terms:
Chickenpox
Measles
Mumps
Parotitis
Rubella
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
 Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on June 17, 2013