Drug Use Investigation for ROTARIX®
|ClinicalTrials.gov Identifier: NCT01636193|
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : August 17, 2015
|Condition or disease||Intervention/treatment|
|Infections, Rotavirus||Biological: Oral Rotarix® Other: Data collection|
|Study Type :||Observational|
|Actual Enrollment :||1607 participants|
|Official Title:||Drug Use Investigation for ROTARIX|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
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.
- Occurrence of Adverse events under clinical practice. [ Time Frame: During the 31-day observation period after each vaccination. ]
- Occurrence of typical symptoms of intussusceptions and bloody stool. [ Time Frame: During the 31-day observation period after each vaccination. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636193
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|