Last updated: 11/04/2018 10:29:54
Integrated safety summary of GSK Biologicals’ HRV vaccine (Rotarix™)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Integrated safety summary of GSK Biologicals’ HRV vaccine (Rotarix™)
Trial description: The aim of the Integrated summary of safety (ISS) was to pool the safety data of 26 placebo controlled HRV vaccine studies completed before 30 April, 2011 in order to generate integrated data on solicited symptoms, unsolicited symptoms and serious adverse events (SAEs).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of unsolicited symptoms
Timeframe: Within the 31-day (Day 0 – 30) follow-up period after each vaccination
Occurrence of SAE(s)
Timeframe: During the entire study period
Occurrence of solicited general symptoms
Timeframe: Within the 8-day (Days 0 - 7) follow-up period after each vaccination
Occurrence of SAE(s)
Timeframe: Within the 31-Day (Day 0 – 30) follow-up period after each vaccination
Secondary outcomes:
Not applicable
Interventions:
Other: Data collection
Enrollment:
102074
Observational study model:
Cohort
Primary completion date:
2012-01-12
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Integrated safety analysis of Rotavirus vaccine
Product
Rotavirus Vaccine
Collaborators
Not applicable
Study date(s)
June 2011 to December 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
6 - 20 Weeks
Accepts healthy volunteers
yes
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 6 and 20 weeks of age at the time of the first vaccination.
- Not Applicable
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female between, and including, 6 and 20 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion criteria:
- Not Applicable
Trial location(s)
No location data available.
Study documents
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
Finalized
Actual primary completion date
2012-01-12
Actual study completion date
2012-01-12
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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