Intussusception Clinical Trial
Official title:
Observational Database Study on the Incidence of Intussusception in Children Aged < 12 Months in Japan
Verified date | October 2012 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Observational |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 12 Months |
Eligibility |
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: |
Observational Model: Case-Only, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of IS in subjects aged < 12 months | Between January 2005 and April 2011 (6 years) | No | |
Primary | Occurrence of age-specific and gender-specific incidence of IS among subjects aged < 12 months in Japan | Between January 2005 and April 2011 (6 years) | No | |
Secondary | Number of IS cases hospitalized more than once among subjects aged < 12 months. | Between January 2005 and April 2011 (6 years) | No | |
Secondary | Occurrence of IS cases by calendar months and year among subjects aged < 12 months | Between January 2005 and April 2011 (6 years) | No |
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