Trials / Completed
CompletedNCT01636193
Drug Use Investigation for ROTARIX®
Drug Use Investigation for ROTARIX
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,607 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2014-09-01
- Completion
- 2014-09-01
- First posted
- 2012-07-10
- Last updated
- 2015-08-17
Source: ClinicalTrials.gov record NCT01636193. Inclusion in this directory is not an endorsement.