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 (CYD00082)

Sanofi

Status: Active, not recruiting

Conditions: Dengue Fever

Study type: Observational

Funder types: Industry

Identifiers

NCT04113330

CYD00082

U1111-1215-0183 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 918 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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• Participants that were withdrawn from the CYD15, CYD13, CYD29, CYD64, or CYD65 study in Colombia study due to "lost to follow-up" and despite various attempts, were not possible to be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

Trial design

918 participants in 1 patient group

Study Group

Description:

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