CompletedNot Applicable

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

54 participantsStarted 2011-11

Plain-language 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.

Who can participate

Age range12 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Occurrence of IS in subjects aged < 12 months

Timeframe: 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

Timeframe: Between January 2005 and April 2011 (6 years)

Trial details

NCT IDNCT01479491

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2011-11

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