Drug Use Investigation for ROTARIX®

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Rotavirus

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01636193

115926

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,607 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 special drug use investigation of Oral Rotarix will be excluded.

Trial design

1,607 participants in 1 patient group

Rota Group

Description:

Subjects will receive Rotarix® as per routine practice.

Treatment:

Other: Data collection

Biological: Oral Rotarix®