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Drug Use Investigation for ROTARIX®

NCT01636193 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1607

Last updated 2015-08-17

No results posted yet for this study

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.

Conditions

  • Infections, Rotavirus

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-09-30
Completion
2014-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01636193 on ClinicalTrials.gov