Clinical Trial: Zika Case Definition and Surveillance Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Prospective Surveillance and Case Definition Study of Zika Virus Disease and Infection in Adolescents and Adults in Latin America in Preparation for an Efficacy Trial of a Zika Virus Whole Virion, Pur
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Sanofi Pasteur, a Sanofi Company
Current Primary Outcome:
- Number of participants with suspected ZVD and virologically confirmed Zika (VCZ) infection in the cohort [ Time Frame: Day 0 to Day 365 ]Number of suspected ZVD and VCZ infections
- Summary of the signs and symptoms accompanying suspected ZVD and VCZ cases in the study participants [ Time Frame: Day 0 to Day 365 ]Occurrence, intensity, and duration of signs and symptoms of ZVD and VCZ cases
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sanofi
Dates:
Date Received: May 16, 2017
Date Started: April 28, 2017
Date Completion: March 2018
Last Updated: May 16, 2017
Last Verified: May 2017
