NCT05011123

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 690 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• Yellow Fever

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-07
• Primary completion: 2022-05-23
• Completion: 2027-04-23
• First posted: 2021-08-18
• Last updated: 2025-05-21
• Results posted: 2025-05-21

Locations

23 sites across 6 countries: Finland, France, Germany, Singapore, Spain, Thailand

Regulatory

• FDA-regulated drug study