Special Drug Use Investigation for ROTARIX®

Special Drug Use Investigation for ROTARIX

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.

Study Overview

• Status: Completed
• Conditions: Infections, Rotavirus
• Intervention / Treatment: Biological: Oral Rotarix®; Other: Data collection

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 10982

Participation Criteria

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.

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 drug use investigation of Oral Rotarix will be excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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; Additional information on intussusception will be collected through interview and by phone-contact.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determination of the incidence of IS	During the 31-day (Day 0 -Day 30) observation period after each vaccination
Determination of the incidence of IS	On the 1 year birthday of the subject

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: July 5, 2012
• First Submitted That Met QC Criteria: July 5, 2012
• First Posted (Estimate): July 10, 2012

Study Record Updates

• Last Update Posted (Estimate): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 29, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Intussusceptions; Special Drug Use Investigation; Rotavirus
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Reoviridae Infections; Rotavirus Infections
• Other Study ID Numbers: 115927

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No