Drug Use Investigation (DUI) of Rotarix®

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: June 25, 2012
Last updated: July 25, 2013
Last verified: July 2013

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.

Condition Intervention
Rotavirus Vaccines
Biological: Oral Rotarix®
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use Investigation for Oral Rotarix® (Safety Investigation of Vaccination for Rotavirus Gastroenteritis)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of Adverse events under clinical practice. [ Time Frame: During the 31-day observation period after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of typical symptoms of intussusceptions and bloody stool. [ Time Frame: During the 31-day observation period after each vaccination. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: June 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (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
Safety data will be collected through the check of health observation diary and interview of vaccinee's parent.

Detailed Description:

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).


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis as part of routine immunisation programme.


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 special drug use investigation of Oral Rotarix will be excluded.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636193

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01636193     History of Changes
Other Study ID Numbers: 115926
Study First Received: June 25, 2012
Last Updated: July 25, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Drug Use Investigation

ClinicalTrials.gov processed this record on April 17, 2014