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: August 28, 2014
Last verified: August 2014

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
Infections, Rotavirus
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)

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 ]

Enrollment: 1607
Study Start Date: June 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 28, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Drug Use Investigation

Additional relevant MeSH terms:
Rotavirus Infections
RNA Virus Infections
Reoviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on March 26, 2015