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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:
NCT00127010
First received: August 4, 2005
Last updated: September 23, 2016
Last verified: September 2016

August 4, 2005
September 23, 2016
November 2005
Not Provided
Antibody levels after vaccination
Same as current
Complete list of historical versions of study NCT00127010 on ClinicalTrials.gov Archive Site
Safety of the study vaccines
Safety of the study vacccines
Not Provided
Not Provided
 
Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
Blinded, Randomized Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Measles-mumps-rubella-varicella Candidate Vaccine Given to Healthy Children During the Second Year of Life
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.
This study included an active control group who received the licensed Priorix (measles, mumps, rubella [MMR] vaccine).
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Measles
  • Rubella
  • Mumps
  • Varicella
Biological: Measles, Mumps, Rubella and Chickenpox (live vaccine)
Other Names:
  • Measles
  • Mumps
  • Rubella and Chickenpox (live vaccine)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
June 2006
Not Provided

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
Both
11 Months to 13 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Netherlands
 
NCT00127010
103388
Not Provided
Yes
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP