Last updated: 11/03/2018 19:02:20
Study on the incidence of intussusception (IS) in children aged < 12 months in Japan
GSK study ID
116259
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Observational database study on the incidence of intussusception in children aged < 12 months in Japan
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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)
Secondary outcomes:
Number of IS cases hospitalized more than once among subjects aged < 12 months.
Timeframe: Between January 2005 and April 2011 (6 years)
Occurrence of IS cases by calendar months and year among subjects aged < 12 months
Timeframe: Between January 2005 and April 2011 (6 years)
Interventions:
Other: Data collection
Enrollment:
54
Observational study model:
Case-Only
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Intussusception
Product
SB444563
Collaborators
Not applicable
Study date(s)
November 2011 to November 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable N/A - 12 months
Accepts healthy volunteers
No
- 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.
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- An IS case should be identified as per the ICD-10 diagnostic code-K56.1 (any-field listed), examination codes, and procedural codes.
A male or female infant aged < 12 months at the time of IS diagnosis and affiliated to the JMDC-MDB database.
Exclusion criteria:
- Not applicable
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2011-07-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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