NCT02570152

A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,004 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Months – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of South Asia.

Detailed description

This study aims to estimate the burden of dengue illness in selected sites South Asia and to prepare sites for the conduct of future vaccine efficacy trials. Operational goals include: * Build long-term collaboration with sites in dengue-endemic regions of South Asia where the incidence of clinical dengue illness can be studied. * Establish dengue surveillance cohorts that can be followed long-term. * Establish operational feasibility of future Phase III studies with regard to recruitment, case capture and sampling procedures. * Prepare sites for participation in Phase III clinical endpoint studies.

Conditions

• Dengue

Interventions

Type	Name	Description
PROCEDURE	Blood sample collection	Blood samples will be collected during the Suspected Dengue First Visit. All study subjects with AFI (fever \[body temperature ≥ 38°C/≥ 100.4°F\] on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart) should be seen at a designated study hospital/clinic by the study physician. The Suspected Dengue First Visit should be scheduled within 7 days from the onset of fever (Days 2-7) and should ideally take place on the second day of fever (Day 2).

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-06-28
• Completion: 2019-06-28
• First posted: 2015-10-07
• Last updated: 2020-07-07
• Results posted: 2020-07-07

Locations

1 site across 1 country: Sri Lanka