NCT03158233

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2018

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

1.6 years

First QC Date

May 16, 2017

Last Update Submit

April 22, 2022

Conditions

Zika Virus Disease

Keywords

Zika virus disease

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • Subject is pregnant (as self-reported)
  • Participation in the 4 weeks preceding enrollment, or planned participation during the present study period, in a clinical trial investigating a vaccine, drug, medical device, or a medical procedure
  • Receipt of any dengue or yellow fever vaccine in the 4 weeks preceding the day of enrollment or planned receipt of any dengue or yellow fever vaccine during the study period
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • History of Zika virus disease, confirmed either clinically, serologically, or virologically
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • Current alcohol abuse or drug addiction
  • Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Identified as an investigator or an employee of the investigator or study center, with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Investigational Site

Floridablanca, Santander Department, Colombia

Location

Investigational Site

Cali, Valle del Cauca Department, Colombia

Location

Investigational site

Tegucigalpa, 11101, Honduras

Location

Investigational Site

Acapulco de Juárez, Guerrero, 39670, Mexico

Location

Investigational Site

Temixco, Morelos, 62587, Mexico

Location

Investigational Site

Carolina, 984, Puerto Rico

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples and urine samples

MeSH Terms

Conditions

Zika Virus Infection

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus Infections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 18, 2017

Study Start

April 29, 2017

Primary Completion

December 19, 2018

Study Completion

December 19, 2018

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

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

Locations

CO(2)ME(2)PR(1)HO(1)