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
1 other identifier
interventional
1,439
4 countries
54
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2005
Shorter than P25 for phase_4
54 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
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 4, 2005
CompletedFirst Posted
Study publicly available on registry
August 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedSeptember 21, 2016
September 1, 2016
6 months
August 4, 2005
September 20, 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 (54)
GSK Investigational Site
Espoo, 02100, Finland
GSK Investigational Site
Lahti, 15140, Finland
GSK Investigational Site
Oulu, 90100, Finland
GSK Investigational Site
Pori, 28120, Finland
GSK Investigational Site
Tampere, 33200, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Vantaa, 01300, Finland
GSK Investigational Site
Bayreuth, Bavaria, 95444, Germany
GSK Investigational Site
Bindlach, Bavaria, 95463, Germany
GSK Investigational Site
Bobingen, Bavaria, 86399, Germany
GSK Investigational Site
Cham, Bavaria, 93413, Germany
GSK Investigational Site
Kempten (Allgäu), Bavaria, 87435, Germany
GSK Investigational Site
Munich, Bavaria, 81241, Germany
GSK Investigational Site
Munich, Bavaria, 81735, Germany
GSK Investigational Site
Nördlingen, Bavaria, 86720, Germany
GSK Investigational Site
Nuremberg, Bavaria, 90473, Germany
GSK Investigational Site
Olching, Bavaria, 82140, Germany
GSK Investigational Site
Tegernsee, Bavaria, 83684, Germany
GSK Investigational Site
Tutzing, Bavaria, 82327, Germany
GSK Investigational Site
Veitshöchheim, Bavaria, 97209, Germany
GSK Investigational Site
Eschwege, Hesse, 37269, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60389, Germany
GSK Investigational Site
Fulda, Hesse, 36037, Germany
GSK Investigational Site
Nidderau, Hesse, 61130, Germany
GSK Investigational Site
Wiesbaden, Hesse, 65205, Germany
GSK Investigational Site
Salzgitter, Lower Saxony, 38226, Germany
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302, Germany
GSK Investigational Site
Bad Oeynhausen, North Rhine-Westphalia, 32549, 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
Goch, North Rhine-Westphalia, 47574, Germany
GSK Investigational Site
Gütersloh, North Rhine-Westphalia, 33332, Germany
GSK Investigational Site
Hille, North Rhine-Westphalia, 32479, Germany
GSK Investigational Site
Kirchlengern, North Rhine-Westphalia, 32278, 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
Mönchengladbach, North Rhine-Westphalia, 41061, Germany
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41236, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, 48159, Germany
GSK Investigational Site
Wesseling, North Rhine-Westphalia, 50389, Germany
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877, Germany
GSK Investigational Site
Arta, 471 00, Greece
GSK Investigational Site
Athens, 11527, Greece
GSK Investigational Site
Komotini, 69100, Greece
GSK Investigational Site
Rhodes, 851 00, Greece
GSK Investigational Site
Thessaloniki, 54636, Greece
GSK Investigational Site
Bydgoszcz, 85-021, Poland
GSK Investigational Site
Krakow, 31-202, Poland
GSK Investigational Site
Poznan, 61-709, Poland
GSK Investigational Site
Siemianowice Śląskie, 41-103, Poland
GSK Investigational Site
Trzebnica, 55-100, Poland
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 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2005
First Posted
August 5, 2005
Study Start
May 1, 2005
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
September 21, 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.