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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

NCT02570152 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2004

Last updated 2020-07-07

Study results available
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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.

Conditions

  • Dengue

Interventions

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).

Sponsors & Collaborators

  • Ministry of Health, Sri Lanka

    collaborator OTHER_GOV

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2019-06-28
Completion
2019-06-28

Countries

  • Sri Lanka

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02570152 on ClinicalTrials.gov