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Study on an Investigational Yellow Fever Vaccine Compared With Stamaril in Adults in Europe and Asia
Sponsor: Sanofi Pasteur, a Sanofi Company
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
Yellow fever vaccine (produced on serum-free Vero cells)
Powder and diluent for suspension for injection - Subcutaneous
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