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

This study has been completed.

First Received: August 4, 2005 Last Updated: January 29, 2009 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
Measles Mumps Rubella Chickenpox	Biological: Measles, Mumps, Rubella and Chickenpox (live vaccine)	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Safety Study
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

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

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104389
Study First Received:	August 4, 2005
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00127023 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

Prophylaxis measles, mumps, rubella and chickenpox

Additional relevant MeSH terms:

Mouth Diseases
RNA Virus Infections
Morbillivirus Infections
Paramyxoviridae Infections
Measles
Rubulavirus Infections
Chickenpox
Sialadenitis
Rubella
Togaviridae Infections

Herpesviridae Infections
Virus Diseases
Rubivirus Infections
Parotid Diseases
DNA Virus Infections
Stomatognathic Diseases
Salivary Gland Diseases
Mumps
Parotitis
Mononegavirales Infections

ClinicalTrials.gov processed this record on November 09, 2009