Drug Use Investigation for ROTARIX®

Infections, Rotavirus Clinical Trial

Official title:

Drug Use Investigation for ROTARIX

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636193
• Other study ID #: 115926
• Status: Completed
• Phase: N/A
• First received: June 25, 2012
• Last updated: August 13, 2015
• Start date: June 2012
• Est. completion date: September 2014

Study information

• Verified date: August 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1607
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Adverse events under clinical practice.		During the 31-day observation period after each vaccination.	No
Primary	Occurrence of typical symptoms of intussusceptions and bloody stool.		During the 31-day observation period after each vaccination.	No