Last updated: 02/21/2024 12:40:14
Effectiveness of RotarixTM vaccine in children aged between 12 weeks to < 5 years, hospitalised for severe gastroenteritis
GSK study ID
116494
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Trial overview
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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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:
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).
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).
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).
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).
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).
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.
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).
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).
Interventions:
Enrollment:
0
Primary completion date:
2015-31-12
Observational study model:
Case-Control
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Infections, Rotavirus, Asthma
Product
SB444563
Collaborators
Not applicable
Study date(s)
December 2014 to December 2015
Type
Observational
Phase
1
Participation criteria
Sex
Female & Male
Age
12 weeks - 5 years
Accepts healthy volunteers
No
- 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.
- For SGE subjects:
- Child in care.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
For SGE subjects:
Exclusion criteria:
- 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.
For SGE subjects:
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
Will be recruiting
Actual primary completion date
2015-31-12
Actual study completion date
2015-31-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website