Special Drug Use Investigation for ROTARIX®

Completed

• Conditions: Infections, Rotavirus
• Interventions: Biological: Oral Rotarix®; Other: Data collection

• Registration Number: NCT01636739
• Lead Sponsor: GlaxoSmithKline

Brief 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®.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-05
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-10
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10982

Inclusion Criteria

• Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis, an indication of Rotarix, will be included in the investigation.

Exclusion Criteria

• All infants included in the drug use investigation of Oral Rotarix will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rota Group	Data collection	Subjects will receive Rotarix® as per routine practice
Rota Group	Oral Rotarix®	Subjects will receive Rotarix® as per routine practice

Primary Outcome Measures

Name	Time	Method
Determination of the incidence of IS	On the 1 year birthday of the subject