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Special Drug Use Investigation for ROTARIX®

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: July 5, 2012
Last updated: October 29, 2015
Last verified: October 2015
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.

Condition Intervention
Infections, Rotavirus Biological: Oral Rotarix® Other: Data collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for ROTARIX

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Determination of the incidence of IS [ Time Frame: During the 31-day (Day 0 -Day 30) observation period after each vaccination ]
  • Determination of the incidence of IS [ Time Frame: On the 1 year birthday of the subject ]

Enrollment: 10982
Study Start Date: July 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rota Group
Subjects will receive Rotarix® as per routine practice
Biological: Oral Rotarix®
2 doses administered orally.
Other: Data collection
Additional information on intussusception will be collected through interview and by phone-contact.

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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01636739

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT01636739     History of Changes
Other Study ID Numbers: 115927
Study First Received: July 5, 2012
Last Updated: October 29, 2015

Keywords provided by GlaxoSmithKline:
Special Drug Use Investigation

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases processed this record on September 19, 2017