The purpose of this study is to assess the safety of vYF (investigational vaccine) compared to the safety of YF-VAX (YF licensed vaccine) in adults aged 18 years up to 60 years. Study details include: * The study duration will be up to approximately 6 months. * One single dose of the study intervention (vYF or YF-VAX) will be administered subcutaneously at the 1st visit. * The visit(V) frequency will be Day(D) 01 (V01) and D29 (V02). Two telephone calls will be planned at D15 and Month(M)6. Number of Participants: A total of 640 participants are expected to be included in the study in a 3:1 ratio (vYF: YF-VAX): Group 1: vYF; N=480 Group 2: YF-VAX; N=160 Study Arms and Duration: Randomized, active control (YF-VAX). 6 months duration per participants. Eligible participants will be randomized in a 3:1 ratio to receive, subcutaneously, a single dose of vYF or YF-VAX vaccines on D01.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
640
Powder and solvent for solution for injection Subcutaneous
Powder and diluent for suspension for injection Subcutaneous
The Hope Clinic of Emory University- Site Number : 8400006
Decatur, Georgia, United States
Velocity Clinical Research-New Orleans- Site Number : 8400004
New Orleans, Louisiana, United States
Johns Hopkins Bloomberg School of Public Health- Site Number : 8400009
Baltimore, Maryland, United States
Saint Louis University Center for Vaccine Development- Site Number : 8400001
St Louis, Missouri, United States
Rochester Clinical Research- Site Number : 8400005
Rochester, New York, United States
Velocity Clinical Research - Providence- Site Number : 8400003
East Greenwich, Rhode Island, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
Number of participants with immediate adverse events
Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
Time frame: Within 30 minutes after vaccination
Number of participants with solicited injection site reactions
Solicited injection site reactions include injection site pain, erythema and swelling
Time frame: Up to 7 days after vaccination
Number of participants with solicited systemic reactions
Solicited systemic reactions include fever, headache, malaise and myalgia
Time frame: Up to 14 days after vaccination
Number of participants with unsolicited adverse events (AEs)
Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions
Time frame: Up to 28 days after vaccination
Number of participants with medical attended adverse events (MAAEs)
MAAEs
Time frame: Up to 28 days after vaccination
Number of participants with adverse events of special interest (AESIs)
AESIs
Time frame: Up to 6 months after vaccination
Number of participants with serious adverse events (SAEs)
SAEs
Time frame: Up to 6 months after vaccination
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