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