Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Asia

Completed

• Conditions: Dengue Fever; Fever

• Registration Number: NCT01218906
• Lead Sponsor: Sanofi

Brief Summary

The purpose of this study is to detect acute febrile episodes and dengue infection in five Asian countries, to assess dengue seroprevalence, and to assess surveillance infrastructure at investigational sites in anticipation of a Phase 3 efficacy trial of a vaccine to prevent dengue infection.

The primary objectives are:

* To identify acute febrile episodes among the cohort in order to detect the presence of dengue infection.

* To develop operational infrastructure for potential Phase III dengue efficacy trial sites.

* To describe the dengue seroprevalence among the cohort at baseline and at the end of the study.

Detailed Description

All participants will make two visits to a study site, an enrollment visit and a termination visit. Additional visits will be made if febrile episodes occur: an acute visit and a convalescent visit. Participants or their parents/guardians will be contacted weekly to monitor the occurrence of febrile episodes and ensure appropriate assessment and care.

No vaccine will be provided or administered in this study.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Primary Completion: 2011-11
• Study Completion: 2012-03
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To provide information on the incidences of febrile episodes and confirmed and probable Dengue fever, and to determine other causes of febrile episodes in the cohort population	Up to 12 months after enrollment