Study to evaluate the occurrence of Dengue in areas with higher concentrations of cases in Brazil
Not Applicable
Recruiting
- Conditions
- DengueC02.081.270
- Registration Number
- RBR-2w55vq
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Written and signed informed consent; male or female at least 6 months of age at the time of enrollment; subject and/or subject’s parent(s) who the investigator believes can comply with the requirements of the protocol and Subject who plans, at the time of enrollment, to remain at same residence/study area during the one year study period
Exclusion Criteria
Child in care; participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator’s judgement and terminal illness or severe mental incapacity
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the incidence of laboratory-confirmed symptomatic dengue infection (all DENV types)
- Secondary Outcome Measures
Name Time Method Estimate the incidence of DENV-type specific laboratory-confirmed and probable symptomatic dengue infection by study site, gender, age-group, and previous dengue exposure (primary or secondary); estimate the prevalence of previous dengue infection(s) (dengue seroprevalence) at baseline; estimate the incidence of primary inapparent dengue infection and estimate the severity of symptomatic dengue (using the 2009 WHO guidelines).