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

NCT01479491 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2012-10-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2011-11-30
Completion
2011-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01479491 on ClinicalTrials.gov