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

Active, not recruiting

• Conditions: Dengue Fever

• Registration Number: NCT04113330
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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 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

Study Timeline

• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-02
• Study Start: 2020-01-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12
• Primary Completion: 2030-01-11
• Study Completion: 2030-01-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 918

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• Participants that were withdrawn from the CYD15, CYD13, CYD29, CYD64, or CYD65 study in Colombia study due to "lost to follow-up" and despite various attempts, were not possible to be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 Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Virologically-confirmed dengue cases	From Day 0 to end of participation (10 years after last dengue vaccination)	Dengue disease confirmed by NS1 Rapid Diagnostic Test in participant with suspected dengue
Type of access to care provided for participant with confirmed dengue	From Day 0 to end of participation (10 years after last dengue vaccination)	Types of access are: urgent care/emergency room visit, hospitalization, medical care for suspected dengue case until dengue confirmation, diagnostic procedures and treatment, and medication
Suspected dengue case as per clinical diagnosis	From Day 0 to end of participation (10 years after last dengue vaccination)	Suspected dengue is defined by high fever (40°C / 140 °F) and at least two of the following: nausea/vomiting, rash, aches and pain, tourniquet test positive, leukopenia, any warning sign

Trial Locations

Locations (1)

Investigational site Colombia; 🇨🇴 Colombia, Colombia