Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04942210
PHASE2

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

Sponsor: Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

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

Interventions

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

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