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ACTIVE NOT RECRUITING
NCT05011123
PHASE2

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

690

Start Date

2021-10-07

Completion Date

2027-04-23

Last Updated

2025-05-21

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

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

Powder and diluent for suspension for injection - Subcutaneous

BIOLOGICAL

Yellow fever vaccine

Powder and diluent for suspension for injection - Subcutaneous

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

Investigational Site Number : 2760001

Hamburg, Germany

Investigational Site Number : 2760002

München, Germany

Investigational Site Number : 2760003

Rostock, Germany

Investigational Site Number : 7020002

Singapore, Singapore

Investigational Site Number : 7020003

Singapore, Singapore

Investigational Site Number : 7020001

Singapore, Singapore

Investigational Site Number : 7240004

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240003

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

Investigational Site Number : 7240002

Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 7240001

Barcelona, Spain

Investigational Site Number : 7640001

Bangkok, Thailand

Investigational Site Number : 7640002

Bangkok, Thailand

Investigational Site Number : 7640003

Nonthaburi, Thailand