Last updated: 08/15/2019 09:30:22

A multicentre study to measure the impact of rotavirus (RV) vaccine on acute gastroenteritis (AGE) hospitalizations in children < 5 years of age attending hospitals in Saudi Arabia

GSK study ID
207271
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A multicentre study to measure the impact of rotavirus (RV) vaccine on acute gastroenteritis (AGE) hospitalizations in children < 5 years of age attending hospitals in Saudi Arabia
Trial description: The purpose of this ecological, database study is to quantify the trends in hospitalizations for AGE in children less than (<) 5 years of age before and after the introduction of Rotarix vaccination into the national immunization program in Saudi Arabia.
The medical discharge certificates of the two hospitals will be reviewed for children < 5 years of age diagnosed and hospitalized for AGE during the study period (2010 – 2017). The required de-identified data will be extracted from the medical discharge certificates.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of all-cause AGE hospitalizations in children aged < 2 years as stated in the medical discharge certificates

Timeframe: Pre-vaccine introduction period (January 2010-December 2012) and Post-vaccine introduction period (January 2015-December 2017)

Secondary outcomes:

Occurrence of age stratified all-cause AGE hospitalizations in children aged < 5 years as stated in the medical discharge certificates

Timeframe: Pre-vaccine introduction period (January 2010-December 2012) and Post-vaccine introduction period (January 2015-December 2017)

Total costs incurred for the hospitalization due to AGE, as obtained from the hospital administration (cost per day in the hospital, cost for any testing, antibiotics, any other treatment, etc.)

Timeframe: Pre-vaccine introduction period (January 2010-December 2012) and Post-vaccine introduction period (January 2015-December 2017)

Interventions:
  • Other: Data collection
    • Enrollment:
    1
    Primary completion date:
    2020-15-04
    Observational study model:
    Ecologic or Community
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    May 2019 to May 2020
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    - 5Years
    Accepts healthy volunteers
    None
    • Children aged less than 5 years of age, diagnosed with and hospitalized due to AGE between January 2010 and December 2017.
    • Not Applicable
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Children aged less than 5 years of age, diagnosed with and hospitalized due to AGE between January 2010 and December 2017.
    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
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    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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