Zika Virus DiseaseNCT03158233
Zika Case Definition and Surveillance Study
An observational study of Zika Virus Disease, run by Sanofi Pasteur, a Sanofi Company at 6 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Zika Virus Disease
- How many people
- 2,400 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 29 Apr 2017to 19 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Colombia2 sites
Investigational Site
Cali, Valle del Cauca Department
Investigational Site
Floridablanca, Santander Department
Mexico2 sites
Investigational Site
Acapulco de Juárez, Guerrero, 39670
Investigational Site
Temixco, Morelos, 62587
About this study
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
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.
Read the detailed 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.
- Conditions
- Zika Virus Disease
- Keywords
- Zika virus disease
- Medical subject headings
- Zika Virus Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with suspected ZVD and virologically confirmed Zika (VCZ) infection in the cohort
Number of suspected ZVD and VCZ infections
Measured: 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
Measured: Day 0 to Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start29 Apr 2017
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zika Virus DiseaseStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158233
- Sponsor's protocol ID
- VAG00001
- Status last verified
- Apr 2022
- First submitted
- 16 May 2017
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03158233
- Acronym / sponsor ID
- VAG00001
- Conditions
- Zika Virus Disease
- Keywords
- Zika virus disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2017 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Zika Virus Disease, run by Sanofi Pasteur, a Sanofi Company at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Colombia, Mexico, Honduras, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with suspected ZVD and virologically confirmed Zika (VCZ) infection in the cohort (time frame: Day 0 to Day 365). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.