Drug Use Investigation for ROTARIX®
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636193
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|