An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Brazil
The purpose of this study is to estimate the incidence of dengue infection in children and adults in geographically distinct locations of Brazil.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Endemic Regions of Brazil|
- To estimate the incidence of laboratory-confirmed symptomatic dengue infection (all DENV types) [ Time Frame: 1 year (Day 0 - Month 12) ] [ Designated as safety issue: No ]
- To 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) [ Time Frame: 1 year (Day 0 - Month 12) ] [ Designated as safety issue: No ]
- To estimate the prevalence of previous dengue infection(s) (dengue seroprevalence) at baseline [ Time Frame: 1 year (Day 0 - Month 12) ] [ Designated as safety issue: No ]
- To estimate the incidence of primary inapparent dengue infection [ Time Frame: 1 year (Day 0 - Month 12) ] [ Designated as safety issue: No ]
- To estimate the severity of symptoms of symptomatic dengue (using the 2009 WHO guidelines) [ Time Frame: 1 year (Day 0 - Month 12) ] [ Designated as safety issue: No ]
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Subjects 6 months of age and older who live in the selected study sites in Brazil.
Procedure: Blood sample collection
Blood samples will be collected at each of the three scheduled study visits (Day 0, Month 6 and Month 12) and any time during the study that dengue is suspected. Samples collected at scheduled visits will be tested for anti-dengue antibodies. Samples collected at visits for dengue suspicion will be tested for dengue infection diagnosis.Other: Data collection
Diary logs will be issued to all subjects at Day 0 and Month 6, as required. Any completed diary logs will be verified, as applicable. Subjects will be given a diary log in the event of the occurrence of a symptom that may be associated with suspected dengue.
The aim of this study is to generate dengue disease burden data including estimates of incidence rates, prevalence data and the clinical presentation of dengue across different age groups.
The study will be conducted in at least three cities: Rio de Janeiro, Salvador, and Manaus. This study will also prepare potential sites for future clinical trials, by setting up the logistics and training staff on site to enroll a cohort of subjects perform dengue surveillance and other study procedures.
Households will be randomly selected from communities where a registry system is implemented. All individuals in the household will be eligible for participating in the study. This study will be sponsored by GSK and co-funded by GSK and Fiocruz. As study sponsor, GSK will delegate some activities to Fiocruz, according to the provisions in their Cooperative Research and Development Agreement (CRADA).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751139
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
|GSK Investigational Site||Recruiting|
|Rio de Janeiro, Brazil, 21040-900|
|Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com|
|Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|