Special Drug Use Investigation for ROTARIX®
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|ClinicalTrials.gov Identifier: NCT01636739|
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : November 2, 2015
|Condition or disease||Intervention/treatment|
|Infections, Rotavirus||Biological: Oral Rotarix® Other: Data collection|
|Study Type :||Observational|
|Actual Enrollment :||10982 participants|
|Official Title:||Special Drug Use Investigation for ROTARIX|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Subjects will receive Rotarix® as per routine practice
Biological: Oral Rotarix®
2 doses administered orally.
Other: Data collection
Additional information on intussusception will be collected through interview and by phone-contact.
- Determination of the incidence of IS [ Time Frame: During the 31-day (Day 0 -Day 30) observation period after each vaccination ]
- Determination of the incidence of IS [ Time Frame: On the 1 year birthday of the subject ]
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): NCT01636739
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|