Zika Case Definition and Surveillance Study

• Register: ClinicalTrials.gov
• Last refreshed on: 2 May 2022
• Main ID: NCT03158233
• Date of registration: 16/05/2017
• Prospective Registration: No
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: Zika Case Definition and Surveillance Study
• Scientific 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, Purified Inactivated Vaccine
• Date of first enrolment: April 29, 2017
• Target sample size: 2400
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03158233
• Study type: Observational

Countries of recruitment

Colombia, Honduras, Mexico, Puerto Rico

Key inclusion & exclusion criteria

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.



Age minimum: 15 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Zika Virus Disease

Primary Outcome(s)

Number of participants with suspected ZVD and virologically confirmed Zika (VCZ) infection in the cohort [Time Frame: Day 0 to Day 365]

Summary of the signs and symptoms accompanying suspected ZVD and VCZ cases in the study participants [Time Frame: Day 0 to Day 365]

Secondary ID(s)

VAG00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors