An observational study in Dengue Fever and Fever, sponsored by Sanofi. Completed at 11 sites in 5 countries. Open to participants aged 2 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-16.
Sponsored by Sanofi · Observational
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:
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.
279 studies on the registry are indexed under Dengue; 45 are open to participants now.
This study's enrollment of 1,500 is above the median of 595 across 78 observational studies indexed under Dengue.
Browse Dengue studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants aged 2 to 14 years in 5 countries in Asia: Malaysia, Indonesia, Thailand, the Philippines and Viet Nam.
Exclusion Criteria :
Temporary Contraindications
A prospective subject should not be included in the study until the following condition and/or symptoms are resolved:
Participants will be examined for febrile illness to diagnose dengue and to identify common causes of fever.
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
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi