Status:
ACTIVE_NOT_RECRUITING
Surveillance of Suspected Dengue Cases for Access to Care for Subjects Identified as Seronegative or Undetermined Before Receiving CYD Dengue Vaccine in Previous Clinical Studies in Colombia
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Dengue Fever
Eligibility:
All Genders
Brief Summary
The primary objective of the study is to identify any suspected dengue case in subjects that received at least one dose of the CYD dengue vaccine who were classified as seronegative or undetermined at...
Detailed Description
The planned duration of each participant's participation in the study will vary according to the date when they received their last CYD Dengue Vaccine. The surveillance will last during 10 year after ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Participants classified as seronegative or undetermined at baseline (by PRNT50 at baseline or anti-NS1 test Post-dose 3) that had received at least one dose of the tetravalent CYD dengue vaccine in the clinical sites of CYD15, CYD13, CYD29, CYD64, or CYD65 studies in Colombia
- Informed consent form or Assent form has been signed and dated by the participant (based on local regulations), and/or informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations)
- Participant (or participant and parent\[s\] or another legally acceptable representative) is (are) able to comply with all study procedures
- Exclusion criteria:
- Participants that were withdrawn from the CYD15, CYD13, CYD29, CYD64, or CYD65 study in Colombia study due to "lost to follow-up" and despite various attempts, were not possible to be contacted
- Participants that cannot be contacted after 3 phone calls, SMS, one home visit and written contact letter/email/WhatsApp
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
January 31 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 15 2028
Estimated Enrollment :
918 Patients enrolled
Trial Details
Trial ID
NCT04113330
Start Date
January 31 2020
End Date
July 15 2028
Last Update
August 8 2025
Active Locations (1)
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1
Investigational site Colombia
Colombia, Colombia