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

1607 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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

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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

Safety data will be collected through the check of health observation diary and interview of vaccinee's parent.

Interventions

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Oral Rotarix®

2 doses administered orally.

Intervention Type BIOLOGICAL

Data collection

Safety data will be collected through the check of health observation diary and interview of vaccinee's parent.

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.