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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03158233
Other study ID # VAG00001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 29, 2017
Est. completion date December 19, 2018

Study information

Verified date April 2022
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 2400
Est. completion date December 19, 2018
Est. primary completion date December 19, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 40 Years
Eligibility Inclusion Criteria: 1. Aged 15 to 40 years on the day of inclusion, currently residing in the site zone, and planning to continue to reside in the site zone for the duration of the study 2. For subjects under the age of majority on the day of inclusion: the assent form has been signed and dated by the subject (if required by local regulations), and the informed consent form has been signed and dated by the parent(s) or legal guardian(s). 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: 1. Subject is pregnant (as self-reported) 2. 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 3. 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 4. Receipt of immune globulins, blood or blood-derived products in the past 3 months 5. 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) 6. History of Zika virus disease, confirmed either clinically, serologically, or virologically 7. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion 8. Current alcohol abuse or drug addiction 9. Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily 10. 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Colombia Investigational Site Cali Valle Del Cauca
Colombia Investigational Site Floridablanca Santander
Honduras Investigational site Tegucigalpa
Mexico Investigational Site Acapulco Guerrero
Mexico Investigational Site Temixco Morelos
Puerto Rico Investigational Site Carolina

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

Colombia,  Honduras,  Mexico,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03343626 - Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants Phase 1
Completed NCT03624946 - Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG) Phase 1
Completed NCT02733796 - Persistence of Zika Virus in Semen After Acute Infection

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