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
NCT01479491
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    Case-Only
    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:

      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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    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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