Infections, Rotavirus Clinical Trial
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
Verified date | March 2015 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | Venezuela: Institutional Review Board |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Weeks to 5 Years |
Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | No | |
Secondary | 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). | No | |
Secondary | 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). | During hospitalisation and after discharge (approximately 12 months from study initiation). | No | |
Secondary | 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). | No | |
Secondary | 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). | No | |
Secondary | 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). | No | |
Secondary | 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. | No | |
Secondary | 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). | No | |
Secondary | 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). | No |
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