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Special Drug Use Investigation for ROTARIX®

NCT01636739 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10982

Last updated 2015-11-02

No results posted yet for this study

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.

Conditions

  • Infections, Rotavirus

Interventions

BIOLOGICAL

Oral Rotarix®

2 doses administered orally.

OTHER

Data collection

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-08-31
Completion
2015-08-31

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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 NCT01636739 on ClinicalTrials.gov