Last updated: 11/03/2018 00:08:23

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

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GSK study ID
103388
See study documents
Clinicaltrials.gov ID
NCT00127010
EudraCT ID
2004-004371-11
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, 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
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:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Measles, Mumps, Rubella and Chickenpox (live vaccine)
    • Enrollment:
    Not applicable
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Measles, Rubella, Mumps, Varicella
    Product
    SB208136, SB209762
    Collaborators
    Not applicable
    Study date(s)
    November 2005 to June 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    11 - 13 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
    Herford, Nordrhein-Westfalen, Germany, 32049
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Loehne, Nordrhein-Westfalen, Germany, 32584
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Minden, Nordrhein-Westfalen, Germany, 32427
    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
    Stuttgart, Baden-Wuerttemberg, Germany, 70469
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Werneck, Bayern, Germany, 97440
    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
    Viersen, Nordrhein-Westfalen, Germany, 41749
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Trier, Rheinland-Pfalz, Germany, 54290
    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
    Boennigheim, Baden-Wuerttemberg, Germany, 74357
    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
    Olching, Bayern, Germany, 82140
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Offenburg, Baden-Wuerttemberg, Germany, 77654
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Frankenthal, Rheinland-Pfalz, Germany, 67227
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Niedernhausen, Hessen, Germany, 65527
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dortmund, Nordrhein-Westfalen, Germany, 44329
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Marbach, Baden-Wuerttemberg, Germany, 71672
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hille, Nordrhein-Westfalen, Germany, 32479
    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
    Flensburg, Schleswig-Holstein, Germany, 24937
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Leuven, Belgium, 3000
    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
    Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wolfenbuettel, Niedersachsen, Germany, 38302
    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
    ROTTERDAM, Netherlands, 3015 GE
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oberkirch, Baden-Wuerttemberg, Germany, 77704
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Brunsbuettel, Schleswig-Holstein, Germany, 25541
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bindlach, Bayern, Germany, 95463
    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
    Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
    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
    Gluecksburg, Schleswig-Holstein, Germany, 24960
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kehl, Baden-Wuerttemberg, Germany, 77694
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
    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
    Cham, Bayern, Germany, 93413
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Ludwigsburg, Baden-Wuerttemberg, Germany, 71634
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Muenster, Nordrhein-Westfalen, Germany, 48163
    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
    Husum, Schleswig-Holstein, Germany, 25813
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Muenchen, Bayern, Germany, 81241
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Weilheim, Bayern, Germany, 82362
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Brussel, Belgium, 1090
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Muenchen, Bayern, Germany, 81735
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Espelkamp, Nordrhein-Westfalen, Germany, 32339
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Eschwege, Hessen, Germany, 37269
    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
    2006-09-06

    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.

    Additional information about the trial

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