Last updated: 11/03/2018 00:34:59

Immunogenicity and safety of a combined vaccine to prevent measles, mumps, rubella and chickenpox diseases

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GSK study ID
104389
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Clinicaltrials.gov ID
NCT00127023
EudraCT ID
2004-005263-19
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    Status
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    Location
    GSK Investigational Site
    Flensburg, Schleswig-Holstein, Germany, 24943
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Leipzig, Sachsen, Germany, 04178
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13055
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10967
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Augsburg, Bayern, Germany, 86163
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rostock, Mecklenburg-Vorpommern, Germany, 18059
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10999
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Frankenthal, Rheinland-Pfalz, Germany, 67227
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Flensburg, Schleswig-Holstein, Germany, 24944
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bodenheim, Rheinland-Pfalz, Germany, 55294
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bindlach, Bayern, Germany, 95463
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 12679
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ludwigsburg, Baden-Wuerttemberg, Germany, 71634
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bochum, Nordrhein-Westfalen, Germany, 44866
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Karlsruhe, Baden-Wuerttemberg, Germany, 76185
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Stuttgart, Baden-Wuerttemberg, Germany, 70469
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Neumuenster, Schleswig-Holstein, Germany, 24534
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Worms, Rheinland-Pfalz, Germany, 67547
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14197
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 12627
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 22307
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Willich, Nordrhein-Westfalen, Germany, 47877
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Krefeld, Nordrhein-Westfalen, Germany, 47798
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Offenburg, Baden-Wuerttemberg, Germany, 77656
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Flensburg, Schleswig-Holstein, Germany, 24937
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Leipzig, Sachsen, Germany, 04317
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Niebuell, Schleswig-Holstein, Germany, 25899
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gerolstein, Rheinland-Pfalz, Germany, 54568
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lobenstein, Thueringen, Germany, 07356
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boennigheim, Baden-Wuerttemberg, Germany, 74357
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Erkrath, Nordrhein-Westfalen, Germany, 40699
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bredstedt, Schleswig-Holstein, Germany, 25821
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Waren, Mecklenburg-Vorpommern, Germany, 17192
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Trier, Rheinland-Pfalz, Germany, 54290
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Salzgitter, Niedersachsen, Germany, 38226
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Muenchen, Bayern, Germany, 81241
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hille, Nordrhein-Westfalen, Germany, 32479
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01169
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mannheim, Baden-Wuerttemberg, Germany, 68161
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Buetzow, Mecklenburg-Vorpommern, Germany, 18246
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Eppelheim, Baden-Wuerttemberg, Germany, 69214
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Trier, Rheinland-Pfalz, Germany, 54294
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Husum, Schleswig-Holstein, Germany, 25813
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Roding, Bayern, Germany, 93426
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bischofswerda, Sachsen, Germany, 01877
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rostock, Mecklenburg-Vorpommern, Germany, 18146
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kirchzarten, Baden-Wuerttemberg, Germany, 79199
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Offenburg, Baden-Wuerttemberg, Germany, 77654
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bretten, Baden-Wuerttemberg, Germany, 75015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mainz, Rheinland-Pfalz, Germany, 55131
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ehingen, Baden-Wuerttemberg, Germany, 89584
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10315
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 22089
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kehl, Baden-Wuerttemberg, Germany, 77694
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13355
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Wolfenbuettel, Niedersachsen, Germany, 38302
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Neuhaus am Rennweg, Thueringen, Germany, 98724
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Marbach, Baden-Wuerttemberg, Germany, 71672
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oberstenfeld, Baden-Wuerttemberg, Germany, 71720
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oberkirch, Baden-Wuerttemberg, Germany, 77704
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fulda, Hessen, Germany, 36037
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Doebeln, Sachsen, Germany, 04720
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Marktheidenfeld, Bayern, Germany, 97828
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Brunsbuettel, Schleswig-Holstein, Germany, 25541
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Nuernberg, Bayern, Germany, 90473
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Harrislee, Schleswig-Holstein, Germany, 24955
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mannheim, Baden-Wuerttemberg, Germany, 68309
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Weimar, Thueringen, Germany, 99425
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ludwigshafen, Rheinland-Pfalz, Germany, 67059
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Moelln, Schleswig-Holstein, Germany, 23879
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pfinztal, Baden-Wuerttemberg, Germany, 76327
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Ettenheim, Baden-Wuerttemberg, Germany, 77955
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Detmold, Nordrhein-Westfalen, Germany, 32756
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Herbolzheim, Baden-Wuerttemberg, Germany, 79336
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Oberhausen, Nordrhein-Westfalen, Germany, 46145
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tettnang, Baden-Wuerttemberg, Germany, 88069
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Stollberg, Sachsen, Germany, 09366
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 22143
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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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