Trials / Completed

CompletedNCT01479491

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

Observational Database Study on the Incidence of Intussusception in Children Aged < 12 Months in Japan

Status: Completed
Phase: —
Study type: Observational
Enrollment: 54 (actual)

Sponsor: GlaxoSmithKline · Industry
Sex: All
Age: 12 Months
Healthy volunteers: Not accepted

Summary

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.

Conditions

Intussusception

Interventions

Type	Name	Description
OTHER	Data collection	Data source will be the Japan Medical Data Centre Company Limited (JMDC) - JMDC Medical Data Bank (JMDC-MDB) database. Aggregated data (age in months and years and gender) for all subjects recorded in the database and subject-level data for IS cases will be extracted from the database. This database will be reviewed to extract data for the period between January 2005 and April 2011. Cases of IS will be identified using the International Classification of Diseases-10 (ICD-10) diagnostic codes, examination codes and procedural codes.

Timeline

Start date: 2011-11-01
Primary completion: 2011-11-01
Completion: 2011-11-01
First posted: 2011-11-24
Last updated: 2012-10-22

Source: ClinicalTrials.gov record NCT01479491. Inclusion in this directory is not an endorsement.