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Drug Use Investigation for ROTARIX®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636193
First Posted: July 10, 2012
Last Update Posted: August 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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 ROTARIX

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. ]
  • Occurrence of typical symptoms of intussusceptions and bloody stool. [ Time Frame: During the 31-day observation period after each vaccination. ]

Enrollment: 1607
Study Start Date: June 2012
Study Completion Date: September 2014
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).
  Eligibility

Information from the National Library of Medicine

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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 as part of routine immunisation programme.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636193


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01636193     History of Changes
Other Study ID Numbers: 115926
First Submitted: June 25, 2012
First Posted: July 10, 2012
Last Update Posted: August 17, 2015
Last Verified: August 2015

Keywords provided by GlaxoSmithKline:
Rotavirus
Rotarix
Drug Use Investigation
Safety

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