Special Drug Use Investigation for ROTARIX®

Infections, Rotavirus Clinical Trial

Official title:

Special Drug Use Investigation for ROTARIX

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636739
• Other study ID #: 115927
• Status: Completed
• Phase: N/A
• First received: July 5, 2012
• Last updated: October 29, 2015
• Start date: July 2012
• Est. completion date: August 2015

Study information

• Verified date: October 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 determine the incidence of intussusceptions (IS) (including suspected cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in Japan.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10982
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• 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 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
Additional information on intussusception will be collected through interview and by phone-contact.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the incidence of IS		During the 31-day (Day 0 -Day 30) observation period after each vaccination	No
Primary	Determination of the incidence of IS		On the 1 year birthday of the subject	No