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
Cancelled
Cancelled
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
Observational study model:
Ecologic or Community
Primary completion date:
2020-15-04
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)

No location data available.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Cancelled
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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