Trials / Withdrawn
WithdrawnNCT01978223
Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis
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
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Weeks – 5 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Stool sample collection | 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. |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2013-11-07
- Last updated
- 2015-03-09
Source: ClinicalTrials.gov record NCT01978223. Inclusion in this directory is not an endorsement.