Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dengue Fever
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-10-02
Enrollment: 918
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Type of access to care provided for participant with confirmed dengue
timeFrame: From Day 0 to end of participation (10 years after last dengue vaccination)
measure: Virologically-confirmed dengue cases
timeFrame: From Day 0 to end of participation (10 years after last dengue vaccination)
measure: Suspected dengue case as per clinical diagnosis
timeFrame: From Day 0 to end of participation (10 years after last dengue vaccination)
Secondary outcomes:
Other outcomes:
Locations:
city: Colombia
country: Colombia
facility: Investigational site Colombia
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: