NCT04942210

Study on an Investigational Yellow Fever Vaccine Compared With YF-VAX in Adults in the USA

Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to YF-VAX in Adults

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 568 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to demonstrate the non-inferiority of the antibody response in terms of seroconversion rate 28 days after vaccine administration of one dose of yellow fever vaccine (vYF) compared to the antibody response after one dose of the YF-VAX control vaccine in yellow fever naïve participants. The secondary objectives of the study are: * To describe the immune response to yellow fever in both vaccine groups before and after vYF or YF-VAX administration. * To describe the safety profile of vYF vaccine in comparison to the safety profile of the control YF-VAX. * To describe the biosafety profile of vYF in comparison to the biosafety profile of the control YF-VAX.

Detailed description

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

Conditions

• Yellow Fever
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Yellow fever vaccine (produced on serum-free Vero cells)	Powder and diluent for suspension for injection Subcutaneous injection
BIOLOGICAL	Yellow fever vaccine	Powder and diluent for suspension for injection Subcutaneous injection

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-06-24
• Completion: 2027-06-29
• First posted: 2021-06-28
• Last updated: 2025-06-18
• Results posted: 2025-06-18

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study