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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00126997
First Posted: August 5, 2005
Last Update Posted: September 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
August 4, 2005
August 5, 2005
September 21, 2016
May 2005
November 2005   (Final data collection date for primary outcome measure)
Antibody levels after vaccination.
Same as current
Complete list of historical versions of study NCT00126997 on ClinicalTrials.gov Archive Site
Safety of the study vaccines.
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety of Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
Blinded, Randomised Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Measles-mumps-rubella-varicella Candidate Vaccine When Given to Healthy Children in Their Second Year of Life
This is a study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals live attenuated measles-mumps-rubella-varicella vaccine given to healthy children in their second year of life.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Mumps
  • Rubella
  • Measles
  • Varicella
Biological: 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
1439
November 2005
November 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
11 Months to 21 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Finland,   Germany,   Greece,   Poland
 
 
NCT00126997
104020
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: 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