Special Drug Use Investigation for ROTARIX®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10982 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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This is non-interventional study conducted in one group received Oral Rotarix®.

Conditions

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Infections, Rotavirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rota Group

Subjects will receive Rotarix® as per routine practice

Oral Rotarix®

Intervention Type BIOLOGICAL

2 doses administered orally.

Data collection

Intervention Type OTHER

Additional information on intussusception will be collected through interview and by phone-contact.

Interventions

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Oral Rotarix®

2 doses administered orally.

Intervention Type BIOLOGICAL

Data collection

Additional information on intussusception will be collected through interview and by phone-contact.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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