Last updated: 11/03/2018 00:34:59
Immunogenicity and safety of a combined vaccine to prevent measles, mumps, rubella and chickenpox diseases
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Measles, Mumps, Rubella and Chickenpox (live vaccine)
Enrollment:
944
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Schuster V et al. (2008) 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. 27(8):724-730.
Schuster 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.
Schuster 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.
Sohita D et al. (2008) Live Attenuated Measles, Mumps, Rubella, and Varicella Zoster Virus Vaccine (Priorix-Tetra). Pediatric Drugs. 10 (5):337-347.
Medical condition
Mumps, Varicella, Rubella, Measles
Product
SB208133, SB208136, SB209762
Collaborators
Not applicable
Study date(s)
May 2005 to November 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
11 - 21 months
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion criteria
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
Trial location(s)
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18059
Status
Study Complete
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24944
Status
Study Complete
Location
GSK Investigational Site
Bodenheim, Rheinland-Pfalz, Germany, 55294
Status
Study Complete
Location
GSK Investigational Site
Ludwigsburg, Baden-Wuerttemberg, Germany, 71634
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44866
Status
Study Complete
Location
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76185
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
Status
Study Complete
Location
GSK Investigational Site
Neumuenster, Schleswig-Holstein, Germany, 24534
Status
Study Complete
Location
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
Status
Study Complete
Location
GSK Investigational Site
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
Status
Study Complete
Location
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
Status
Study Complete
Location
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
Status
Study Complete
Location
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
Status
Study Complete
Location
GSK Investigational Site
Offenburg, Baden-Wuerttemberg, Germany, 77656
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Study Complete
Location
GSK Investigational Site
Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
Status
Study Complete
Location
GSK Investigational Site
Niebuell, Schleswig-Holstein, Germany, 25899
Status
Study Complete
Location
GSK Investigational Site
Gerolstein, Rheinland-Pfalz, Germany, 54568
Status
Study Complete
Location
GSK Investigational Site
Lobenstein, Thueringen, Germany, 07356
Status
Study Complete
Location
GSK Investigational Site
Boennigheim, Baden-Wuerttemberg, Germany, 74357
Status
Study Complete
Location
GSK Investigational Site
Erkrath, Nordrhein-Westfalen, Germany, 40699
Status
Study Complete
Location
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
Status
Study Complete
Location
GSK Investigational Site
Waren, Mecklenburg-Vorpommern, Germany, 17192
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Salzgitter, Niedersachsen, Germany, 38226
Status
Study Complete
Location
GSK Investigational Site
Hille, Nordrhein-Westfalen, Germany, 32479
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
Location
GSK Investigational Site
Buetzow, Mecklenburg-Vorpommern, Germany, 18246
Status
Study Complete
Location
GSK Investigational Site
Eppelheim, Baden-Wuerttemberg, Germany, 69214
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54294
Status
Study Complete
Location
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bischofswerda, Sachsen, Germany, 01877
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18146
Status
Study Complete
Location
GSK Investigational Site
Kirchzarten, Baden-Wuerttemberg, Germany, 79199
Status
Study Complete
Location
GSK Investigational Site
Offenburg, Baden-Wuerttemberg, Germany, 77654
Status
Study Complete
Location
GSK Investigational Site
Bretten, Baden-Wuerttemberg, Germany, 75015
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Ehingen, Baden-Wuerttemberg, Germany, 89584
Status
Study Complete
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
Status
Study Complete
Location
GSK Investigational Site
Neuhaus am Rennweg, Thueringen, Germany, 98724
Status
Study Complete
Location
GSK Investigational Site
Marbach, Baden-Wuerttemberg, Germany, 71672
Status
Study Complete
Location
GSK Investigational Site
Oberstenfeld, Baden-Wuerttemberg, Germany, 71720
Status
Study Complete
Location
GSK Investigational Site
Oberkirch, Baden-Wuerttemberg, Germany, 77704
Status
Study Complete
Location
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
Status
Study Complete
Location
GSK Investigational Site
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
Status
Study Complete
Location
GSK Investigational Site
Marktheidenfeld, Bayern, Germany, 97828
Status
Study Complete
Location
GSK Investigational Site
Brunsbuettel, Schleswig-Holstein, Germany, 25541
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Harrislee, Schleswig-Holstein, Germany, 24955
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68309
Status
Study Complete
Location
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67059
Status
Study Complete
Location
GSK Investigational Site
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
Status
Study Complete
Location
GSK Investigational Site
Moelln, Schleswig-Holstein, Germany, 23879
Status
Study Complete
Location
GSK Investigational Site
Pfinztal, Baden-Wuerttemberg, Germany, 76327
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
Status
Study Complete
Location
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
Status
Study Complete
Location
GSK Investigational Site
Herbolzheim, Baden-Wuerttemberg, Germany, 79336
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oberhausen, Nordrhein-Westfalen, Germany, 46145
Status
Study Complete
Location
GSK Investigational Site
Tettnang, Baden-Wuerttemberg, Germany, 88069
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-25-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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