NCT04113330

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

Surveillance of Suspected Dengue Cases for Access to Care for Subjects Identified as Seronegative or Undetermined at Baseline and Who Received CYD Dengue Vaccine in CYD15, CYD13, CYD29, CYD64, CYD65 Trials in Colombia

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 918 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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 baseline (according to PRNT50 at baseline, or anti-non-structural protein 1 \[NS1\] test Post-dose 3) in the Colombian study sites of CYD15, CYD13, CYD29, CYD64, CYD65 trials in order to allow appropriate access to care until the completion of 10 years after the last CYD Dengue Vaccine received by each participant

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 the last CYD dengue vaccination of included participants

Conditions

• Dengue Fever

Timeline

• Start date: 2020-01-31
• Primary completion: 2028-07-15
• Completion: 2028-07-15
• First posted: 2019-10-02
• Last updated: 2025-08-08

Locations

1 site across 1 country: Colombia