Clinical trial NCT01978223: Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis
Official title: Case-control Study to Evaluate the Vaccine Effectiveness of RotarixTM Against Rotavirus Severe Gastroenteritis Among Hospitalised Children Aged 12 Weeks to < 5 Years, in Venezuela
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infections, Rotavirus
Keywords: Rotarix™
Case-control
Venezuela
Vaccine effectiveness
Rotavirus Severe Gastroenteritis
Children
Hospitalised
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-11-07
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 12 weeks to \< 5 years, hospitalised for SGE in the study hospitals.

Brief summary: This study aims to estimate the effectiveness of Rotarix™ vaccine against Rotavirus severe gastroenteritis (RV SGE) among hospitalised children aged between 12 weeks and \< 5 years, in Venezuela and to assess the current disease burden after introduction of the vaccine.

Detailed description: The data generated in this study will be useful for public health officers and policy makers in confirming the country-wide public health benefit of Rotarix™.

No vaccine will be administered during this study.

Eligibility criteria: Inclusion Criteria:

For SGE subjects:

* A male or female child aged 12 weeks to \< 5 years at the time of hospital admission/ ED stay. The subject becomes ineligible on the fifth birthday.
* Subject admitted to (or who will have an ED stay at) the study hospital(s) for SGE during the study period.
* Onset of SGE ≤ 14 days prior to admission/ ED stay.
* Written/thumb printed informed consent obtained from the parent(s)/legally acceptable representative(s) (LAR (s)) of the subject.

For Cases:

• Laboratory confirmed (i.e. by ELISA) RV-positive stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation.

For Controls:

* Subject admitted to (or who will have an ED stay at) the same study hospital(s) for SGE as that of the case during the study period.
* Laboratory confirmed (i.e. by ELISA) RV-negative stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation.
* Subjects born within ± 2 weeks from the date of birth of the case.

Exclusion Criteria:

For SGE subjects:

* Child in care.
* Hospitalisation is unrelated to GE.
* Onset of SGE \> 48 hours after admission to (or ED stay at) the hospital.
* Subject has digestive tube anomalies, chronic gastrointestinal disease or uncorrected congenital abnormalities.
* Subject with immunodeficiency.
* Subjects who live out of the federative entity where hospital(s) are located.

For Controls:

• Subject has previously participated as case in this study.

Primary outcomes:
measure: Full vaccination status of Rotarix™ (2 doses) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls).
timeFrame: During hospitalisation and after discharge (approximately 12 months from study initiation).
Secondary outcomes:
measure: Full/partial vaccination status (at least one dose of Rotarix™) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls).
timeFrame: During hospitalisation and after discharge (approximately 12 months from study initiation).
measure: Occurrence of specific RV genotype among the enrolled RV SGE children with full/partial vaccination status (at least one dose of Rotarix™ with the vaccine is administered at least 2 weeks before hospitalisation).
timeFrame: During hospitalisation and after discharge (approximately 12 months from study initiation).
measure: Occurrence of RV SGE in children by age at hospitalisation with full/partial vaccination status (at least one dose of Rotarix™ with the vaccine administered at least 2 weeks before hospitalisation).
timeFrame: During hospitalisation and after discharge (approximately 12 months from study initiation).
measure: Occurrence of RV SGE in children by severity with assessment of severity of RV SGE cases by the Vesikari scale.
timeFrame: During hospitalisation and after discharge (approximately 12 months from study initiation).
measure: Occurrence of SGE [≤14 days prior to admission/ Emergency Department (ED) stay] among all hospitalised children.
timeFrame: During hospitalisation and after discharge (approximately 12 months from study initiation).
measure: Occurrence of RV SGE hospital admissions/ ED stays among children hospitalised at the study hospital(s) for SGE.
timeFrame: At hospital admission/ ED stay or during the first 48 hours of hospitalisation.
measure: Occurrence of RV SGE admissions/ ED stays by age of the child (at hospitalisation) and month of year.
timeFrame: During hospitalisation and after discharge (approximately 12 months from study initiation).
measure: Occurrence of RV genotypes among children admitted to (or who have had an ED stay at) the study hospital(s) for SGE.
timeFrame: During hospitalisation and after discharge (approximately 12 months from study initiation).
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: