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As vaccine coverage rates have drastically improved in Venezuela, the study lost its objective to show positive impact of the vaccine to stimulate higher usage
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Children hospitalised for SGE, aged 12 weeks to < 5 years at the time of hospital admission/ED stay and whose stool samples test positive for RV by enzyme linked immunosorbent assay (ELISA) at a GSK designated laboratory. |
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| Controls | Children hospitalised for SGE, aged 12 weeks to < 5 years at the time of hospital admission/ ED stay, whose stool samples test negative for RV by enzyme linked immunosorbent assay at a GSK designated laboratory and who will be matched to the cases by date of birth and the hospital of admission/ ED stay. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool sample collection | Procedure | Stool samples will be collected from all children enrolled in the study, within 48 hours of admission to the hospital/ ED. Stool samples will be tested to determine the presence or absence of rotavirus (RV). Additionally, for RV-positive cases, the stool samples will be tested to determine the RV genotypes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During hospitalisation and after discharge (approximately 12 months from study initiation). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). |
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Inclusion Criteria:
For SGE subjects:
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:
Exclusion Criteria:
For SGE subjects:
For Controls:
• Subject has previously participated as case in this study.
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Children aged 12 weeks to < 5 years, hospitalised for SGE in the study hospitals.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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Stool sample
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| 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). | 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. | 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. | 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. | 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. | 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. | During hospitalisation and after discharge (approximately 12 months from study initiation). |