Last updated: 11/07/2018 09:59:13
Drug Use Investigation for ROTARIX®
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Drug Use Investigation for ROTARIX
Trial description: This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of Adverse events under clinical practice.
Timeframe: During the 31-day observation period after each vaccination.
Occurrence of typical symptoms of intussusceptions and bloody stool.
Timeframe: During the 31-day observation period after each vaccination.
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Oral Rotarix®
Other: Data collection
Enrollment:
1607
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Kimura T et al. (2015) Safety of live attenuated human rotavirus vaccine, oral, ROTARIX® liquid formulation in clinical practice: Findings from drug use investigation. Prog Med. 35(3):577-584.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
June 2012 to September 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
Yes
- Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis, an indication of Rotarix, will be included in the investigation.
- All infants included in the special drug use investigation of Oral Rotarix will be excluded.
Inclusion and exclusion criteria
Inclusion criteria:
Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis, an indication of Rotarix, will be included in the investigation.
Exclusion criteria:
All infants included in the special drug use investigation of Oral Rotarix will be excluded.
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
Not applicable
Actual study completion date
2014-02-09
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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