Zika Case Definition and Surveillance Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03158233 |
Recruitment Status :
Completed
First Posted : May 18, 2017
Last Update Posted : April 25, 2022
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Condition or disease |
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Zika Virus Disease |
Study Type : | Observational |
Actual Enrollment : | 2400 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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, Purified Inactivated Vaccine |
Actual Study Start Date : | April 29, 2017 |
Actual Primary Completion Date : | December 19, 2018 |
Actual Study Completion Date : | December 19, 2018 |

- 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
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 15 Years to 40 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
- 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:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158233
Colombia | |
Investigational Site | |
Floridablanca, Santander, Colombia | |
Investigational Site | |
Cali, Valle Del Cauca, Colombia | |
Honduras | |
Investigational site | |
Tegucigalpa, Honduras, 11101 | |
Mexico | |
Investigational Site | |
Acapulco, Guerrero, Mexico, 39670 | |
Investigational Site | |
Temixco, Morelos, Mexico, 62587 | |
Puerto Rico | |
Investigational Site | |
Carolina, Puerto Rico, 984 |
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT03158233 |
Other Study ID Numbers: |
VAG00001 |
First Posted: | May 18, 2017 Key Record Dates |
Last Update Posted: | April 25, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Zika virus disease |
Virus Diseases Zika Virus Infection Infections Arbovirus Infections |
Vector Borne Diseases Flavivirus Infections Flaviviridae Infections RNA Virus Infections |