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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2011-01-03
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)

No location data available.

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
Finalized
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website