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Study on an Investigational Yellow Fever Vaccine Compared With YF-VAX in Adults in the USA
Sponsor: Sanofi Pasteur, a Sanofi Company
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.
Official title: Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to YF-VAX in Adults
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
568
Start Date
2021-07-01
Completion Date
2027-06-29
Last Updated
2025-06-18
Healthy Volunteers
Yes
Conditions
Interventions
Yellow fever vaccine (produced on serum-free Vero cells)
Powder and diluent for suspension for injection Subcutaneous injection
Yellow fever vaccine
Powder and diluent for suspension for injection Subcutaneous injection
Locations (11)
Emory University Decatur- Site Number : 8400005
Decatur, Georgia, United States
Velocity Clinical Research- New Orleans Site Number : 8400008
New Orleans, Louisiana, United States
Johns Hopkins Bloomberg School of Public Health (JHSPH)- Site Number : 8400004
Baltimore, Maryland, United States
Harvard University Medical School- Site Number : 8400002
Boston, Massachusetts, United States
Saint Louis University- Site Number : 8400003
St Louis, Missouri, United States
Meridian Clinical Research- Site Number : 8400009
Omaha, Nebraska, United States
SUNY Upstate Medical University Global Health Institute Site Number : 8400006
East Syracuse, New York, United States
New York University Langone Medical Center Site Number : 8400013
New York, New York, United States
Rochester Clinical Research, Inc.- Site Number : 8400010
Rochester, New York, United States
Velocity Clinical Research - Providence Site Number : 8400015
East Greenwich, Rhode Island, United States
J Lewis Research Inc- Site Number : 8400012
Salt Lake City, Utah, United States