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

NCT04113330 | Active Not Recruiting

• 2 other identifiers: CYD00082U1111-1215-0183
• Study Type: observational
• Target: 918
• Locations: 1 country
• Sites: 1

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

Conditions

Dengue Fever

Outcome Measures

Primary Outcomes (3)

• Type of access to care provided for participant with confirmed dengue

  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

  From Day 0 to end of participation (10 years after last dengue vaccination)

• Virologically-confirmed dengue cases

  Dengue disease confirmed by NS1 Rapid Diagnostic Test in participant with suspected dengue

  From Day 0 to end of participation (10 years after last dengue vaccination)

• Suspected dengue case as per clinical diagnosis

  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

  From Day 0 to end of participation (10 years after last dengue vaccination)

Study Arms (1)

Study Group

Participant vaccinated with CYD Dengue Vaccine and classified as seronegative or undetermined at baseline in previous dengue studies in Colombia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participant vaccinated with CYD dengue vaccine and classified as seronegative or undetermined at baseline in the Colombian study sites of CYD15, CYD13, CYD29, CYD64, or CYD65 trials

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Investigational site Colombia

Colombia, Colombia

Location

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 2, 2019
• Study Start: January 31, 2020
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 15, 2028
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

CO (1)