Loading clinical trials...

Phase 3 Randomized, Modified Double-blind, Active-controlled Safety Study on vYF in Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT07002060•Sanofi

View on ClinicalTrials.gov

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

Age

18 - 59 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.
•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

Exclusion Criteria

•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)
•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.
+7 more criteria

Locations (7)

The Hope Clinic of Emory University- Site Number : 8400006

Decatur, Georgia, United States

Velocity Clinical Research-New Orleans- Site Number : 8400004

New Orleans, Louisiana, United States

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

Baltimore, Maryland, United States

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

St Louis, Missouri, United States

Rochester Clinical Research- Site Number : 8400005

Rochester, New York, United States

Velocity Clinical Research - Providence- Site Number : 8400003

East Greenwich, Rhode Island, United States

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, United States

Key Dates

Start Date

May 22, 2025

Primary Completion Date

January 20, 2026

Completion Date

January 20, 2026

Last Updated

February 2, 2026

Enrollment

640

ACTUAL participants

Conditions

Yellow Fever Immunization

Interventions

Yellow fever vaccine (live)

BIOLOGICAL

YF vaccine (live)

BIOLOGICAL

A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population

NCT07103148

Yellow Fever Immunization

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions