Special Drug Use Investigation for ROTARIX®

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Rotavirus

Treatments: Other: Data collection; Biological: Oral Rotarix®

Study type: Observational

Funder types: Industry

Identifiers

NCT01636739

115927

Details and patient eligibility

About

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.

Full description

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

Enrollment: 10,982 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

10,982 participants in 1 patient group

Rota Group

Description:

Subjects will receive Rotarix® as per routine practice

Treatment:

Other: Data collection

Biological: Oral Rotarix®