Trials / Completed
CompletedNCT01636739
Special Drug Use Investigation for ROTARIX®
Special Drug Use Investigation for ROTARIX
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10,982 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
Summary
This study aims to determine the incidence of intussusceptions (IS) (including suspected cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in Japan.
Detailed description
This is non-interventional study conducted in one group received Oral Rotarix®.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Oral Rotarix® | 2 doses administered orally. |
| OTHER | Data collection | Additional information on intussusception will be collected through interview and by phone-contact. |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2012-07-10
- Last updated
- 2015-11-02
Source: ClinicalTrials.gov record NCT01636739. Inclusion in this directory is not an endorsement.