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
1 other identifier
interventional
N/A
3 countries
48
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2005
Shorter than P25 for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2005
CompletedFirst Posted
Study publicly available on registry
August 5, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedSeptember 26, 2016
September 1, 2016
August 4, 2005
September 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Antibody levels after vaccination
Secondary Outcomes (1)
Safety of the study vaccines
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (48)
GSK Investigational Site
Brussels, 1090, Belgium
GSK Investigational Site
Leuven, 3000, Belgium
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, 88348, Germany
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, 74357, Germany
GSK Investigational Site
Ehingen, Baden-Wurttemberg, 89584, Germany
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694, Germany
GSK Investigational Site
Kirchzarten, Baden-Wurttemberg, 79199, Germany
GSK Investigational Site
Ludwigsburg, Baden-Wurttemberg, 71634, Germany
GSK Investigational Site
Marbach, Baden-Wurttemberg, 71672, Germany
GSK Investigational Site
Oberkirch, Baden-Wurttemberg, 77704, Germany
GSK Investigational Site
Offenburg, Baden-Wurttemberg, 77654, Germany
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469, Germany
GSK Investigational Site
Tauberbischofsheim, Baden-Wurttemberg, 97941, Germany
GSK Investigational Site
Tettnang, Baden-Wurttemberg, 88069, Germany
GSK Investigational Site
Bindlach, Bavaria, 95463, Germany
GSK Investigational Site
Cham, Bavaria, 93413, Germany
GSK Investigational Site
Munich, Bavaria, 81241, Germany
GSK Investigational Site
Munich, Bavaria, 81735, Germany
GSK Investigational Site
Olching, Bavaria, 82140, Germany
GSK Investigational Site
Weilheim, Bavaria, 82362, Germany
GSK Investigational Site
Werneck, Bavaria, 97440, Germany
GSK Investigational Site
Eschwege, Hesse, 37269, Germany
GSK Investigational Site
Fulda, Hesse, 36037, Germany
GSK Investigational Site
Niedernhausen, Hesse, 65527, Germany
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44866, Germany
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756, Germany
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44329, Germany
GSK Investigational Site
Espelkamp, North Rhine-Westphalia, 32339, Germany
GSK Investigational Site
Herford, North Rhine-Westphalia, 32049, Germany
GSK Investigational Site
Hille, North Rhine-Westphalia, 32479, Germany
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533, Germany
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47798, Germany
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584, Germany
GSK Investigational Site
Minden, North Rhine-Westphalia, 32427, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, 48163, Germany
GSK Investigational Site
Porta Westfalica, North Rhine-Westphalia, 32457, Germany
GSK Investigational Site
Viersen, North Rhine-Westphalia, 41749, Germany
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227, Germany
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290, Germany
GSK Investigational Site
Brunsbüttel, Schleswig-Holstein, 25541, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937, Germany
GSK Investigational Site
Glücksburg, Schleswig-Holstein, 24960, Germany
GSK Investigational Site
Husum, Schleswig-Holstein, 25813, Germany
GSK Investigational Site
Neumünster, Schleswig-Holstein, 24534, Germany
GSK Investigational Site
Neuhaus am Rennweg, Thuringia, 98724, Germany
GSK Investigational Site
Rotterdam, 3015 GE, Netherlands
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2005
First Posted
August 5, 2005
Study Start
November 1, 2005
Study Completion
June 1, 2006
Last Updated
September 26, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.