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

NCT01751139 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3300

Last updated 2020-04-27

Study results available
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Summary

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

Conditions

  • Dengue

Interventions

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.

Sponsors & Collaborators

  • Tropical Disease Foundation

    collaborator OTHER

  • Goncalo Moniz Research Center

    collaborator OTHER

  • Evandro Chagas Research Institute, Bio-Manguinhos Technology and Immunology Institute

    collaborator OTHER_GOV

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-18
Primary Completion
2018-12-20
Completion
2018-12-20

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT01751139 on ClinicalTrials.gov