Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Asia
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Asia|
- 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 [ Time Frame: Up to 12 months after enrollment ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Cohort Population (Case )
Participants will be examined for febrile illness to diagnose dengue and to identify common causes of fever.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218906
|Bandung, Indonesia, 40161|
|Jakarta, Indonesia, 10430|
|Kuala Lumpur, Malaysia|
|Cebu City, Philippines, 6000|
|Muntinlupa City, Philippines|
|San Pablo, Philippines|
|Bangkok, Thailand, 10400|
|My Tho City, Vietnam|
|Study Director:||Medical Director||Sanofi Pasteur SA.|