Phase 3 Randomized, Modified Double-blind, Active-controlled Safety Study on vYF in Adults

Last updated: September 17, 2025
Sponsor: Sanofi
Overall Status: Active - Not Recruiting

Phase

3

Condition

Fever

Treatment

Yellow fever vaccine (live)

YF vaccine (live)

Clinical Study ID

NCT07002060
VYF00019
  • Ages 18-59
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to assess the safety of vYF (investigational vaccine) compared to the safety of YF-VAX (YF licensed vaccine) in adults aged 18 years up to 60 years.

Study details include:

  • The study duration will be up to approximately 6 months.

  • One single dose of the study intervention (vYF or YF-VAX) will be administered subcutaneously at the 1st visit.

  • The visit(V) frequency will be Day(D) 01 (V01) and D29 (V02). Two telephone calls will be planned at D15 and Month(M)6.

Number of Participants:

A total of 640 participants are expected to be included in the study in a 3:1 ratio (vYF: YF-VAX):

Group 1: vYF; N=480 Group 2: YF-VAX; N=160

Study Arms and Duration:

Randomized, active control (YF-VAX). 6 months duration per participants. Eligible participants will be randomized in a 3:1 ratio to receive, subcutaneously, a single dose of vYF or YF-VAX vaccines on D01.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged from 18 years to 60 years on the day of inclusion

  • Participants who are healthy as determined by medical evaluation including medicalhistory and physical examination

  • A female participant is eligible to participate if she is not pregnant orbreastfeeding and one of the following conditions applies:

  • Is of non-childbearing potential. To be considered of non-childbearingpotential, a female must be post-menopausal for at least 1 year, or surgicallysterile.

OR

-Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.

  • A female participant of childbearing potential must have a negative highly sensitivepregnancy test (urine or serum as required by local regulation) before any dose ofstudy intervention on D01 and will be repeated on D29 to confirm the participant isstill not pregnant within the 28 days of vaccine administration

  • Able to attend all scheduled visits and to comply with all study procedures Informedconsent

  • Informed consent form has been signed and dated

Exclusion

Exclusion Criteria:

  • Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3months)

  • Known history of laboratory evidence of HIV infection

  • Known history of hepatitis B or hepatitis C seropositivity

  • Known history of flavivirus (FV) infection

  • Known systemic hypersensitivity to any of the study intervention components, orhistory of a life-threatening reaction to the vaccine used in the study or to avaccine containing any of the same substances

  • Personal or family history of thymic pathology (thymoma, thymectomy, or myasthenia)

  • Chronic illness that, in the opinion of the investigator, is at a stage where itmight interfere with trial conduct or completion , including malignancy, such asleukemia or lymphoma

  • Moderate or severe acute illness/infection (according to Investigator judgment) onthe day of vaccination or febrile illness (temperature ≥ 38°C [or ≥ 100.4°F]). Aprospective participant should not be included in the study until the condition hasresolved or the febrile event has subsided.

  • Alcohol, prescription drug, or substance abuse that, in the opinion of theInvestigator, might interfere with the study conduct or completion

  • Receipt of any vaccine in the 4 weeks preceding the study vaccination or plannedreceipt of any vaccine in the 4 weeks following the study vaccination (prior toVisit 2 on D29), except for influenza vaccination, which may be received at least 2weeks before study vaccine. This exception includes pandemic influenza vaccinesincluding monovalent pandemic influenza vaccines.

  • Previous vaccination against a FV disease at any time including yellow fever (YF)with an investigational or marketed vaccine

  • Receipt of immune globulins, blood or blood-derived products in the past 6 months

  • Administration of any anti-viral within 2 months preceding the vaccination and up tothe 6 weeks following the vaccination

  • Participation at the time of study enrollment (or in the 4 weeks preceding the studyvaccination) or planned participation during the course of the study in anotherclinical study investigating a vaccine, drug, medical device, or medical procedure

  • Deprived of freedom by an administrative or court order, or in an emergency setting,or hospitalized involuntarily

  • Identified as an Investigator or employee of the Investigator or study center withdirect involvement in the proposed study, or identified as an immediate familymember (ie, parent, spouse, natural or adopted child) of the Investigator oremployee with direct involvement in the proposed study

  • Planned travel in a YF endemic country within 6 months of investigational vaccineadministration

Study Design

Total Participants: 640
Treatment Group(s): 2
Primary Treatment: Yellow fever vaccine (live)
Phase: 3
Study Start date:
May 22, 2025
Estimated Completion Date:
January 08, 2026

Connect with a study center

  • The Hope Clinic of Emory University- Site Number : 8400006

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • Velocity Clinical Research-New Orleans- Site Number : 8400004

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Velocity Clinical Research-New Orleans- Site Number : 8400004

    New Orleans 4335045, Louisiana 4331987 70119
    United States

    Site Not Available

  • Johns Hopkins Bloomberg School of Public Health- Site Number : 8400009

    Baltimore 4347778, Maryland 4361885 21205
    United States

    Site Not Available

  • Saint Louis University Center for Vaccine Development- Site Number : 8400001

    St Louis 4407066, Missouri 4398678 63104
    United States

    Site Not Available

  • Velocity Clinical Research

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Rochester Clinical Research- Site Number : 8400005

    Rochester, New York 14610
    United States

    Site Not Available

  • Rochester Clinical Research- Site Number : 8400005

    Rochester 5134086, New York 5128638 14610
    United States

    Site Not Available

  • Velocity Clinical Research - Providence- Site Number : 8400003

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Velocity Clinical Research - Providence- Site Number : 8400003

    East Greenwich 5221875, Rhode Island 5224323 02818
    United States

    Site Not Available

  • J. Lewis Research, Inc. / Foothill Family Clinic

    Salt Lake City, Utah 84109
    United States

    Site Not Available

  • J. Lewis Research, Inc. / Foothill Family Clinic

    Salt Lake City 5780993, Utah 5549030 84109
    United States

    Site Not Available

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