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

NCT05011123 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 4 other identifiers: VYF03U1111-1260-46502022-502047-352020-005566-33
• Study Type: interventional
• Target: 690
• Locations: 6 countries
• Sites: 23

Brief 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.

Conditions

Yellow Fever

Outcome Measures

Primary Outcomes (1)

• Percentage of Yellow Fever-naive Participants Who Achieved Seroconversion 28 Days Post Dose 1 Enrolled in European Union

  Seroconversion was defined as a 4-fold increase in Nab titers as compared to the pre-vaccination value. YF-naive participants (or negative) at baseline corresponded to participants with no detectable YF Ab titers before vaccination. The YF NAb titers were determined using a validated live virus microneutralization (MN) assay. Percentages are rounded off to the tenth decimal place.

  28 days post dose 1 (Day 29)

Secondary Outcomes (12)

• Percentage of Participants Who Achieved Seroconversion 28 Days Post Dose 1 Enrolled in European Union

  28 days post dose 1 (Day 29)

• Percentage of Participants Who Achieved Seroconversion Enrolled in European Union and Asia

  Days 1, 11, 29, Month 6, Years 1 and 2

• Percentage of Participants Who Achieved Seroprotection to Yellow Fever Virus Enrolled in European Union and Asia

  Days 1, 11, 29, Month 6, Years 1 and 2

• Geometric Mean Titers (GMTs) of Antibodies Against Yellow Fever Virus in Participants Enrolled in European Union and Asia

  Days 1, 11, 29, Month 6, Years 1 and 2

• Geometric Mean Titers Ratio (GMTRs) of Antibodies Against Yellow Fever Virus in Participants Enrolled in European Union and Asia

  Days 1, 11, 29, Month 6, Years 1 and 2

Study Arms (2)

Group 1

EXPERIMENTAL

1 injection of vYF vaccine at Day 1

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

Group 2

ACTIVE COMPARATOR

1 injection of Stamaril vaccine at Day 1

Biological: Yellow fever vaccine

Interventions

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

Powder and diluent for suspension for injection - Subcutaneous

Also known as: vYF vaccine

Group 1

Yellow fever vaccine BIOLOGICAL

Powder and diluent for suspension for injection - Subcutaneous

Also known as: Stamaril

Group 2

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Not applicable for Finland
• 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)
• 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

You may not qualify if:

• 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).
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
• Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
• Chronic illness (7) 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 ≥ 100.4°F or 38°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
• Administration of any anti-viral within 2 months preceding the vaccination and planned administration up to the 6 weeks following the vaccination.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (23)

Investigational Site Number : 2460001

Helsinki, 00290, Finland

Location

Investigational Site Number : 2460002

Tampere, 33100, Finland

Location

Investigational Site Number : 2460003

Turku, 20520, Finland

Location

Investigational Site Number : 2500008

Lyon, 69004, France

Location

Investigational Site Number : 2500006

Montpellier, 34295, France

Location

Investigational Site Number : 2500001

Nantes, 44093, France

Location

Investigational Site Number : 2500007

Nîmes, 30029, France

Location

Investigational Site Number : 2500009

Paris, 75014, France

Location

Investigational Site Number : 2500004

Pierre-Bénite, 69495, France

Location

Investigational Site Number : 2760004

Berlin, 10117, Germany

Location

Investigational Site Number : 2760001

Hamburg, 20359, Germany

Location

Investigational Site Number : 2760002

München, 80802, Germany

Location

Investigational Site Number : 2760003

Rostock, 18057, Germany

Location

Investigational Site Number : 7020002

Singapore, 119074, Singapore

Location

Investigational Site Number : 7020003

Singapore, 169608, Singapore

Location

Investigational Site Number : 7020001

Singapore, Singapore

Location

Investigational Site Number : 7240004

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Investigational Site Number : 7240003

L'Hospitalet de Llobregat, Barcelona [Barcelona], 08907, Spain

Location

Investigational Site Number : 7240002

Madrid, Madrid, Comunidad de, 28046, Spain

Location

Investigational Site Number : 7240001

Barcelona, 08036, Spain

Location

Investigational Site Number : 7640001

Bangkok, 10330, Thailand

Location

Investigational Site Number : 7640002

Bangkok, Thailand

Location

Investigational Site Number : 7640003

Nonthaburi, 11000, Thailand

Location

MeSH Terms

Conditions

Yellow Fever

Interventions

Yellow Fever Vaccine

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610 ext: 6#

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators, Sponsor, and Study staff who conduct the safety assessment and the participant will not know which vaccine is administered. Only the study staff who prepare and administer the vaccine and are not involved with the safety evaluation ("vaccinator") will know which vaccine is administered.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 18, 2021
• Study Start: October 7, 2021
• Primary Completion: May 23, 2022
• Study Completion (Estimated): April 23, 2027
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

FR (6); FI (3); SG (3); DE (4); ES (4); TH (3)