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

This study has been completed.

First Received on August 4, 2005. Last Updated on January 5, 2012 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00127023

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 III

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:

MedlinePlus related topics: Chickenpox Measles Mumps Rubella Shingles

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:

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:

Schuster V, Otto W, Maurer L, Tcherepnine P, Pfletschinger U, Kindler K, Soemantri P, Walther U, Macholdt U, Douha M, Pierson P, Willems P. Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. Pediatr Infect Dis J. 2008 Aug;27(8):724-30.

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:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00127023 History of Changes
Other Study ID Numbers:	104389
Study First Received:	August 4, 2005
Last Updated:	January 5, 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 February 09, 2012