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Yellow Fever ImmunizationPhase 3NCT07002060

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

A Phase 3 study testing Yellow fever vaccine (live) and YF vaccine (live) in people with Yellow Fever Immunization, run by Sanofi at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Yellow Fever Immunization
What is being tested?
Yellow fever vaccine (live) and YF vaccine (live)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
640 participants
Where
7 sitesUnited States
Study dates
22 May 2025to 20 Jan 2026
Phase
Phase 3
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 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged from 18 years to 60 years on the day of inclusion
  • Participants who are healthy as determined by medical evaluation including medical history and physical examination
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
  • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile.
  • 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.
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  • A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) before any dose of study intervention on D01 and will be repeated on D29 to confirm the participant is still not pregnant within the 28 days of vaccine administration
  • Able to attend all scheduled visits and to comply with all study procedures Informed consent
  • Informed consent form has been signed and dated

Who cannot join

  • 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 corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • 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, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances
  • Personal or family history of thymic pathology (thymoma, thymectomy, or myasthenia)
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  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion , including malignancy, such as leukemia or lymphoma
  • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38°C [or ≥ 100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
  • Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination (prior to Visit 2 on D29), except for influenza vaccination, which may be received at least 2 weeks before study vaccine. This exception includes pandemic influenza vaccines including 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 to the 6 weeks following the vaccination
  • Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the course of the study in another clinical 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 with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
  • Planned travel in a YF endemic country within 6 months of investigational vaccine administration

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

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

    Baltimore, Maryland, 21205

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

    Decatur, Georgia, 30030

  • Velocity Clinical Research - Providence- Site Number : 8400003

    East Greenwich, Rhode Island, 02818

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

    New Orleans, Louisiana, 70119

  • Rochester Clinical Research- Site Number : 8400005

    Rochester, New York, 14610

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

    Salt Lake City, Utah, 84109

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

    St Louis, Missouri, 63104

Other trials in United States

About this study

Official title: A Phase 3 Randomized, Modified Double-blind, Active-controlled Study to Assess the Safety of vYF, Yellow Fever Vaccine, in Adults Aged 18 Years up to 60 Years

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:

Read more
  • 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.

Being tested
Yellow fever vaccine (live), YF vaccine (live)
Keywords
Yellow fever
Medical subject headings
Yellow Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yellow fever vaccine (live)Biological

    Also called vYF vaccine

    Powder and solvent for solution for injection Subcutaneous

  • YF vaccine (live)Biological

    Also called YF-VAX vaccine, YF-VAX

    Powder and diluent for suspension for injection Subcutaneous

Study groups in NCT07002060
Study groupRoleWhat they receive
vYF vaccineExperimentalA single dose on Day 01
Receives: Biological: Yellow fever vaccine (live)
YF-VAX vaccineActive comparatorA single dose on Day 01
Receives: Biological: YF vaccine (live)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with immediate adverse events

    Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination

    Measured: Within 30 minutes after vaccination

  2. Number of participants with solicited injection site reactions

    Solicited injection site reactions include injection site pain, erythema and swelling

    Measured: Up to 7 days after vaccination

  3. Number of participants with solicited systemic reactions

    Solicited systemic reactions include fever, headache, malaise and myalgia

    Measured: Up to 14 days after vaccination

  4. Number of participants with unsolicited adverse events (AEs)

    Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions

    Measured: Up to 28 days after vaccination

  5. Number of participants with medical attended adverse events (MAAEs)

    MAAEs

    Measured: Up to 28 days after vaccination

  6. Number of participants with adverse events of special interest (AESIs)

    AESIs

    Measured: Up to 6 months after vaccination

  7. Number of participants with serious adverse events (SAEs)

    SAEs

    Measured: Up to 6 months after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study start22 May 2025
  3. Primary completion20 Jan 2026
  4. Study completion20 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
640 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07002060
Sponsor's protocol ID
VYF00019
Status last verified
Jan 2026
First submitted
23 May 2025
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Yellow fever vaccine (live) and YF vaccine (live) in people with Yellow Fever Immunization, run by Sanofi at 7 sites in United States.

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 9 inclusion and 17 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 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 immediate adverse events (time frame: Within 30 minutes after vaccination). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07002060.

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 2 Feb 2026.

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