Last updated: 06/28/2019 09:20:14
Special 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: Special Drug Use Investigation for ROTARIX
Trial description: This study aims to determine the incidence of intussusceptions (IS) (including suspected cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in Japan.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Determination of the incidence of IS
Timeframe: During the 31-day (Day 0 –Day 30) observation period after each vaccination
Determination of the incidence of IS
Timeframe: On the 1 year birthday of the subject
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Oral Rotarix®
Other: Data collection
Enrollment:
10982
Observational study model:
Cohort
Primary completion date:
2015-31-08
Time perspective:
Prospective
Clinical publications:
Yanagita Y et al. (2016) Investigation of the Occurrence of Intussusception after Administration of Oral Live Attenuated Human Vaccine (Rotarix®): Results from Special Drug Use Investigation. Prog Med. 36(8):1121-1125.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
July 2012 to August 2015
Type
Observational
Phase
4
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 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 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
Protocol
Available language(s): English
Clinical study report
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
2015-31-08
Actual study completion date
2015-31-08
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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