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This prospective, surveillance study will assess the operational Zika virus definition for use in future Zika purified inactivated virus (ZIKV) vaccine efficacy trials in order to identify Zika virus disease (ZVD) cases among the study cohort.
This prospective, multicenter, cohort study will conduct active and passive surveillance for ZVD and determine its prevalence and seroconversion incidence in areas of Latin America experiencing Zika epidemic activity. A description of the occurrence of dengue virus and chikungunya virus infections in the cohort may also be provided as differential diagnosis of ZVD.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with suspected ZVD and virologically confirmed Zika (VCZ) infection in the cohort | Number of suspected ZVD and VCZ infections | Day 0 to Day 365 |
| Summary of the signs and symptoms accompanying suspected ZVD and VCZ cases in the study participants | Occurrence, intensity, and duration of signs and symptoms of ZVD and VCZ cases | Day 0 to Day 365 |
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Inclusion Criteria:
For subjects at or over the age of majority on the day of inclusion: the informed consent form has been signed and dated.
3) Subject (and parent/guardian if subject is under the age of majority) able to attend all scheduled visits and to comply with all study procedures 4) In good health, based on medical history and physical examination Exclusion Criteria:
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Prospective, multi-center, cohort study in 2400 subjects aged 15 to 40 years at enrollment in 4 countries in Latin America: Colombia, Honduras, Mexico, and Puerto Rico
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Floridablanca | Santander Department | Colombia | |||
| Investigational Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D000071243 | Zika Virus Infection |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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Blood samples and urine samples
| Cali |
| Valle del Cauca Department |
| Colombia |
| Investigational site | Tegucigalpa | 11101 | Honduras |
| Investigational Site | Acapulco de Juárez | Guerrero | 39670 | Mexico |
| Investigational Site | Temixco | Morelos | 62587 | Mexico |
| Investigational Site | Carolina | 984 | Puerto Rico |
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |