Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
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
1 other identifier
interventional
944
1 country
85
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
participants targeted
Target at P75+ for phase_3
Started May 2005
Shorter than P25 for phase_3
85 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
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedSeptember 21, 2016
September 1, 2016
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 (85)
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, 88348, Germany
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, 74357, Germany
GSK Investigational Site
Bretten, Baden-Wurttemberg, 75015, Germany
GSK Investigational Site
Ehingen, Baden-Wurttemberg, 89584, Germany
GSK Investigational Site
Eppelheim, Baden-Wurttemberg, 69214, Germany
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955, Germany
GSK Investigational Site
Herbolzheim, Baden-Wurttemberg, 79336, Germany
GSK Investigational Site
Karlsruhe, Baden-Wurttemberg, 76185, 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
Mannheim, Baden-Wurttemberg, 68161, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68309, Germany
GSK Investigational Site
Marbach, Baden-Wurttemberg, 71672, Germany
GSK Investigational Site
Oberkirch, Baden-Wurttemberg, 77704, Germany
GSK Investigational Site
Oberstenfeld, Baden-Wurttemberg, 71720, Germany
GSK Investigational Site
Offenburg, Baden-Wurttemberg, 77654, Germany
GSK Investigational Site
Offenburg, Baden-Wurttemberg, 77656, Germany
GSK Investigational Site
Pfinztal, Baden-Wurttemberg, 76327, 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
Augsburg, Bavaria, 86163, Germany
GSK Investigational Site
Bindlach, Bavaria, 95463, Germany
GSK Investigational Site
Marktheidenfeld, Bavaria, 97828, Germany
GSK Investigational Site
Munich, Bavaria, 81241, Germany
GSK Investigational Site
Nuremberg, Bavaria, 90473, Germany
GSK Investigational Site
Roding, Bavaria, 93426, Germany
GSK Investigational Site
Hamburg, Hamburg, 22089, Germany
GSK Investigational Site
Hamburg, Hamburg, 22143, Germany
GSK Investigational Site
Hamburg, Hamburg, 22307, Germany
GSK Investigational Site
Fulda, Hesse, 36037, Germany
GSK Investigational Site
Salzgitter, Lower Saxony, 38226, Germany
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302, Germany
GSK Investigational Site
Bützow, Mecklenburg-Vorpommern, 18246, Germany
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18059, Germany
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18146, Germany
GSK Investigational Site
Waren, Mecklenburg-Vorpommern, 17192, 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
Erkrath, North Rhine-Westphalia, 40699, Germany
GSK Investigational Site
Heiligenhaus, North Rhine-Westphalia, 42579, 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
Oberhausen, North Rhine-Westphalia, 46145, Germany
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877, Germany
GSK Investigational Site
Bad Kreuznach, Rhineland-Palatinate, 55543, Germany
GSK Investigational Site
Bodenheim, Rhineland-Palatinate, 55294, Germany
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227, Germany
GSK Investigational Site
Gerolstein, Rhineland-Palatinate, 54568, Germany
GSK Investigational Site
Ludwigshafen am Rhein, Rhineland-Palatinate, 67059, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290, Germany
GSK Investigational Site
Trier, Rhineland-Palatinate, 54294, Germany
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547, Germany
GSK Investigational Site
Bischofswerda, Saxony, 01877, Germany
GSK Investigational Site
Döbeln, Saxony, 04720, Germany
GSK Investigational Site
Dresden, Saxony, 01169, Germany
GSK Investigational Site
Leipzig, Saxony, 04178, Germany
GSK Investigational Site
Leipzig, Saxony, 04317, Germany
GSK Investigational Site
Stollberg, Saxony, 09366, Germany
GSK Investigational Site
Bredstedt, Schleswig-Holstein, 25821, Germany
GSK Investigational Site
Brunsbüttel, Schleswig-Holstein, 25541, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24943, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24944, Germany
GSK Investigational Site
Harrislee, Schleswig-Holstein, 24955, Germany
GSK Investigational Site
Husum, Schleswig-Holstein, 25813, Germany
GSK Investigational Site
Mölln, Schleswig-Holstein, 23879, Germany
GSK Investigational Site
Neumünster, Schleswig-Holstein, 24534, Germany
GSK Investigational Site
Niebüll, Schleswig-Holstein, 25899, Germany
GSK Investigational Site
Berlin, State of Berlin, 10315, Germany
GSK Investigational Site
Berlin, State of Berlin, 10967, Germany
GSK Investigational Site
Berlin, State of Berlin, 10999, Germany
GSK Investigational Site
Berlin, State of Berlin, 12627, Germany
GSK Investigational Site
Berlin, State of Berlin, 12679, Germany
GSK Investigational Site
Berlin, State of Berlin, 13055, Germany
GSK Investigational Site
Berlin, State of Berlin, 13355, Germany
GSK Investigational Site
Berlin, State of Berlin, 14197, Germany
GSK Investigational Site
Bad Lobenstein, Thuringia, 07356, Germany
GSK Investigational Site
Neuhaus am Rennweg, Thuringia, 98724, Germany
GSK Investigational Site
Weimar, Thuringia, 99425, Germany
Related Publications (4)
Schuster V, Otto W, Maurer L, Tcherepnine P, Pfletschinger U, Kindler K, Soemantri P, Walther U, Macholdt U, Douha M, Pierson P, Willems P. Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. Pediatr Infect Dis J. 2008 Aug;27(8):724-30. doi: 10.1097/INF.0b013e318170bb22.
PMID: 18600190BACKGROUNDSchuster V et al. Immunogenicity of a Refrigerator-Stable Tetravalent MMRV Vaccine after One and Two Doses. Presented at the 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 3-5 May 2006.
BACKGROUNDSchuster V et al. Tolerability of a Refrigerator-Stable Tetravalent MMRV vaccine after One and Two Doses. Presented at the 12th International Congress on Infectious Diseases (ICID), Lisbon, Portugal, 15-18 June 2006.
BACKGROUNDDhillon S, Curran MP. Live attenuated measles, mumps, rubella, and varicella zoster virus vaccine (Priorix-Tetra). Paediatr Drugs. 2008;10(5):337-47. doi: 10.2165/00148581-200810050-00007.
PMID: 18754700BACKGROUND
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
- DOUBLE
- 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
May 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.