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Study on an Investigational Yellow Fever Vaccine Compared With Stamaril in Adults in Europe and Asia | Clinical Trials | Clareo Health

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Study on an Investigational Yellow Fever Vaccine Compared With Stamaril in Adults in Europe and Asia

Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to Stamaril in Adults

NCT05011123•Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

Summary

VYF03 is a phase II, randomized, parallel-group prevention study with 2 arms, active-controlled (Stamaril), observer-blind, multi-center study to assess the non-inferiority of the immune response, in terms of seroconversion rates of the investigational vaccine candidate vYF to the licensed Stamaril, in adults aged 18 years up to 60 years in Europe (EU). The safety and immunogenicity profile of vYF in a cohort of Asian population of Chinese origin outside of China will also be described. The study will also assess the immunogenicity profiles and the safety profiles of vYF and Stamaril. Participants will be randomized in a 2:1 ratio to receive a single subcutaneous injection of either the vYF vaccine (380 participants in EU and 80 participants of Chinese origin in Asia) or Stamaril (190 participants in EU and 40 participants of Chinese origin in Asia), on Day 01. The duration of each participant's participation will be approximately 5 years.

Detailed Description

The duration of each participant's participation will be approximately 5 years.

Eligibility

Age

18 - 59 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Aged 18 years up to 60 years\* on the day of inclusion
•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 postmenopausal for at least 1 year, or surgically sterile OR Is of childbearing potential and agrees to use an effective contraceptive method (1) or abstinence (1) from at least 4 weeks prior to study intervention administration until at least 4 weeks (2) after study intervention administration.
•\*18 to 60 years means from the day of the 18th birthday up to the day before the 60th birthday
•1. Not applicable for Finland
•2. Except for French participants which have to apply 12 weeks contraception 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 Day 1 and the test will be repeated on D29 to confirm the participant is still not pregnant within 28 days of vaccine administration.
•\- Informed consent form has been signed and dated (3)
•3. For participants aged less than 21 years in Singapore, an informed consent form has been signed and dated by both the participant and the parent(s) or another legally acceptable representative
•* Able to attend all scheduled visits and to comply with all study procedures
•* For participants enrolled in Asian countries as part of the additional cohort only: know Chinese origin, defined as having at least one biological parent of Chinese origin, and will be self-reported by the participant

Exclusion Criteria

•Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the first 2 years of the 5-year follow-up in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Enrollment in another study after the first 2 years is permitted, assuming that it does not exclude participation in this study.
•* 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 4), except for influenza vaccination, which may be received at least 2 weeks before study vaccines (4). This exception includes all influenza vaccines including monovalent pandemic influenza vaccines.
•* Previous vaccination against a FV disease at any time including YF with either the study vaccine or another vaccine.
•* Receipt of immune globulins, blood, or blood-derived products in the past 6 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 corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
•* Known history of any FV infection.
•* Known systemic hypersensitivity to any of the vaccine components, eggs, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
•* Known history or laboratory evidence of HIV infection (5).
•* Known history or laboratory evidence of hepatitis B or hepatitis C infection (6).
•* Personal or family history of thymic pathology (thymoma, thymectomy, or myasthenia).
+11 more criteria

Locations (23)

Investigational Site Number : 2460001

Helsinki, Finland

Investigational Site Number : 2460002

Tampere, Finland

Investigational Site Number : 2460003

Turku, Finland

Investigational Site Number : 2500008

Lyon, France

Investigational Site Number : 2500006

Montpellier, France

Investigational Site Number : 2500001

Nantes, France

Investigational Site Number : 2500007

Nîmes, France

Investigational Site Number : 2500009

Paris, France

Investigational Site Number : 2500004

Pierre-Bénite, France

Investigational Site Number : 2760004

Berlin, Germany

Key Dates

Start Date

October 7, 2021

Primary Completion Date

May 23, 2022

Completion Date

April 23, 2027

Last Updated

May 21, 2025

Enrollment

690

ACTUAL participants

Conditions

Yellow Fever

Interventions

Yellow fever vaccine (produced on serum-free Vero cells)

BIOLOGICAL

Yellow fever vaccine

BIOLOGICAL

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RECRUITINGNA

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Yellow Fever Vaccine

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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: May 21, 2025Data 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.

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Study on an Investigational Yellow Fever Vaccine Compared With Stamaril in Adults in Europe and Asia

Inclusion Criteria

Exclusion Criteria

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

VAC-SIP-YF (Vaccination- Safety & Immunogenicity During Pregnancy- Yellow Fever)

Immunity Period After One Dose of Yellow Fever Vaccine in Adults and Children (Paraiba Study)

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

A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL

Turnover of Antigen Specific Lymphocytes and Monocytes After Immunization With the 17D Yellow Fever Vaccine