Drug Use Investigation for ROTARIX®

August 13, 2015 updated by: GlaxoSmithKline

Drug Use Investigation for ROTARIX

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

1607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of Adverse events under clinical practice.
Time Frame: During the 31-day observation period after each vaccination.
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.
During the 31-day observation period after each vaccination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 10, 2012

Study Record Updates

Last Update Posted (Estimate)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 115926

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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