NCT01751139

An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Brazil

An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Endemic Regions of Brazil

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,300 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to estimate the incidence of dengue infection in children and adults in geographically distinct locations of Brazil.

Detailed description

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).

Conditions

• Dengue

Interventions

Type	Name	Description
PROCEDURE	Blood sample collection	Blood samples will be collected at each study visit (Day 0, Month 6, Month 12, Month 24, Month 36 and Month 48) 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 every visit, except Month 48 (Day 0, Month 6, Month 12, Month 24, and Month 36), 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.

Timeline

• Start date: 2014-02-18
• Primary completion: 2018-12-20
• Completion: 2018-12-20
• First posted: 2012-12-17
• Last updated: 2020-04-27
• Results posted: 2020-03-26

Locations

5 sites across 1 country: Brazil