Study on the Incidence of Intussusception (IS) in Children Aged < 12 Months in Japan

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Intussusception

Treatments: Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01479491

116259

Details and patient eligibility

About

This study aims to analyse baseline data on IS in order to monitor the possibility of increased risk of IS in children aged <12 months after introduction of the Rotarix vaccination in Japan.

Enrollment: 54 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A male or female infant aged < 12 months at the time of IS diagnosis and affiliated to the JMDC-MDB database.
• An IS case should be identified as per the ICD-10 diagnostic code-K56.1 (any-field listed), examination codes, and procedural codes.

Exclusion criteria

Not applicable

Trial design

54 participants in 1 patient group

Case Group

Description:

Children aged \< 12 months presenting with IS and covered by the Japan Medical Data Centre Company Limited (JMDC), Tokyo referred to as the JMDC Medical Data Bank (JMDC-MDB).

Treatment:

Other: Data collection