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

Dengue Fever Clinical Trial

— CYD00082  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04113330
• Other study ID #: CYD00082
• Secondary ID: U1111-1215-0183
• Status: Active, not recruiting
• Start date: January 31, 2020
• Est. completion date: January 11, 2030

Study information

• Verified date: January 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 918
• Est. completion date: January 11, 2030
• Est. primary completion date: January 11, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dengue
• Dengue Fever

Locations

Country	Name	City	State
Colombia	Investigational site Colombia	Colombia

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)