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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Occurrence of IS in subjects aged < 12 months [ Time Frame: Between January 2005 and April 2011 (6 years) ]
  • Occurrence of age-specific and gender-specific incidence of IS among subjects aged < 12 months in Japan [ Time Frame: Between January 2005 and April 2011 (6 years) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of IS cases hospitalized more than once among subjects aged < 12 months. [ Time Frame: Between January 2005 and April 2011 (6 years) ]
  • Occurrence of IS cases by calendar months and year among subjects aged < 12 months [ Time Frame: Between January 2005 and April 2011 (6 years) ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: November 22, 2011
Date Started: November 2011
Date Completion:
Last Updated: October 18, 2012
Last Verified: October 2012