Last updated: 07/11/2019 09:50:15

Integrated Summary Output (ISO) on febrile convulsions

GSK study ID
MMRV (208136) - Meta-analysis
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
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: Integrated Summary Output (ISO) on febrile convulsions
Trial description: The aim of this study was to assess the possible risk of febrile convulsions and to present the risk benefit analysis based on the assumption that there is a class effect of MMRV (Measles-Mumps-Rubella-Varicella) vaccines with regard to febrile convulsions.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Percentage of subjects reporting the occurrence of febrile convulsion as per Brighton level 1-4

Timeframe: Between Day 5 and Day 12 (inclusive) post-vaccination regardless of the study dose

Secondary outcomes:

Percentage of subjects reporting the occurrence of febrile convulsion as per Brighton level 1-3

Timeframe: Between Day 5 and Day 12 (inclusive) post-vaccination regardless of the study dose

Percentage of subjects reporting the occurrence of febrile convulsion as per Brighton level 1-4

Timeframe: Within the 31-day (Days 0-30) post vaccination period regardless of the study dose

Percentage of subjects reporting the occurrence of febrile convulsion as per Brighton level 1-3

Timeframe: Within the 43-day (Days 0-42) post vaccination period regardless of the study dose

Percentage of subjects reporting the occurrence of febrile convulsion as per Brighton level 1-3

Timeframe: Between Day 7 and Day 10 (inclusive) post-vaccination regardless of the study dose

Percentage of subjects reporting the occurrence of febrile convulsion as per Brighton level 1-3

Timeframe: Within the 31-day (Days 0-30) post vaccination period regardless of the study dose

Percentage of subjects reporting the occurrence of febrile convulsion as per Brighton level 1-4

Timeframe: Within the 43-day (Days 0-42) post vaccination period regardless of the study dose

Percentage of subjects reporting the occurrence of febrile convulsion as per Brighton level 1-4

Timeframe: Between Day 7 and Day 10 (inclusive) post-vaccination regardless of the study dose

Interventions:
  • Other: Data Collection
    • Enrollment:
    17086
    Primary completion date:
    2011-01-03
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Measles, Mumps, Rubella, Varicella
    Product
    Combined Measles, Mumps, Rubella, Varicella Vaccine
    Collaborators
    Not applicable
    Study date(s)
    March 2011 to March 2011
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable - 6 Year
    Accepts healthy volunteers
    Yes
    • Not applicable
    • Not applicable
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Not applicable
    Exclusion criteria:
    • Not applicable

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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
    2011-01-03
    Actual study completion date
    2011-01-03

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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