Drug Use Investigation (DUI) of Rotarix®
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Drug Use Investigation for Oral Rotarix® (Safety Investigation of Vaccination for Rotavirus Gastroenteritis)|
- Occurrence of Adverse events under clinical practice. [ Time Frame: During the 31-day observation period after each vaccination. ] [ Designated as safety issue: No ]
- Occurrence of typical symptoms of intussusceptions and bloody stool. [ Time Frame: During the 31-day observation period after each vaccination. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Subjects will receive Rotarix® as per routine practice.
Biological: Oral Rotarix®
2 doses administered orally.Other: Data collection
Safety data will be collected through the check of health observation diary and interview of vaccinee's parent.
This is non-interventional study conducted in one group received Oral Rotarix®. This surveillance is abbreviated as SMILER (Surveillance and Monitoring In Living clinical Experience for Rotarix).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636193
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|