Phase
Condition
Fever
Treatment
Yellow fever vaccine (live)
YF vaccine (live)
Clinical Study ID
Ages 18-59 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged from 18 years to 60 years on the day of inclusion
Participants who are healthy as determined by medical evaluation including medicalhistory and physical examination
A female participant is eligible to participate if she is not pregnant orbreastfeeding and one of the following conditions applies:
Is of non-childbearing potential. To be considered of non-childbearingpotential, a female must be post-menopausal for at least 1 year, or surgicallysterile.
OR
-Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.
A female participant of childbearing potential must have a negative highly sensitivepregnancy test (urine or serum as required by local regulation) before any dose ofstudy intervention on D01 and will be repeated on D29 to confirm the participant isstill not pregnant within the 28 days of vaccine administration
Able to attend all scheduled visits and to comply with all study procedures Informedconsent
Informed consent form has been signed and dated
Exclusion
Exclusion Criteria:
Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3months)
Known history of laboratory evidence of HIV infection
Known history of hepatitis B or hepatitis C seropositivity
Known history of flavivirus (FV) infection
Known systemic hypersensitivity to any of the study intervention components, orhistory of a life-threatening reaction to the vaccine used in the study or to avaccine containing any of the same substances
Personal or family history of thymic pathology (thymoma, thymectomy, or myasthenia)
Chronic illness that, in the opinion of the investigator, is at a stage where itmight interfere with trial conduct or completion , including malignancy, such asleukemia or lymphoma
Moderate or severe acute illness/infection (according to Investigator judgment) onthe day of vaccination or febrile illness (temperature ≥ 38°C [or ≥ 100.4°F]). Aprospective participant should not be included in the study until the condition hasresolved or the febrile event has subsided.
Alcohol, prescription drug, or substance abuse that, in the opinion of theInvestigator, might interfere with the study conduct or completion
Receipt of any vaccine in the 4 weeks preceding the study vaccination or plannedreceipt of any vaccine in the 4 weeks following the study vaccination (prior toVisit 2 on D29), except for influenza vaccination, which may be received at least 2weeks before study vaccine. This exception includes pandemic influenza vaccinesincluding monovalent pandemic influenza vaccines.
Previous vaccination against a FV disease at any time including yellow fever (YF)with an investigational or marketed vaccine
Receipt of immune globulins, blood or blood-derived products in the past 6 months
Administration of any anti-viral within 2 months preceding the vaccination and up tothe 6 weeks following the vaccination
Participation at the time of study enrollment (or in the 4 weeks preceding the studyvaccination) or planned participation during the course of the study in anotherclinical study investigating a vaccine, drug, medical device, or medical procedure
Deprived of freedom by an administrative or court order, or in an emergency setting,or hospitalized involuntarily
Identified as an Investigator or employee of the Investigator or study center withdirect involvement in the proposed study, or identified as an immediate familymember (ie, parent, spouse, natural or adopted child) of the Investigator oremployee with direct involvement in the proposed study
Planned travel in a YF endemic country within 6 months of investigational vaccineadministration
Study Design
Connect with a study center
The Hope Clinic of Emory University- Site Number : 8400006
Decatur 4191124, Georgia 4197000 30030
United StatesSite Not Available
Velocity Clinical Research-New Orleans- Site Number : 8400004
New Orleans, Louisiana 70119
United StatesSite Not Available
Velocity Clinical Research-New Orleans- Site Number : 8400004
New Orleans 4335045, Louisiana 4331987 70119
United StatesSite Not Available
Johns Hopkins Bloomberg School of Public Health- Site Number : 8400009
Baltimore 4347778, Maryland 4361885 21205
United StatesSite Not Available
Saint Louis University Center for Vaccine Development- Site Number : 8400001
St Louis 4407066, Missouri 4398678 63104
United StatesSite Not Available
Velocity Clinical Research
Omaha, Nebraska 68134
United StatesSite Not Available
Rochester Clinical Research- Site Number : 8400005
Rochester, New York 14610
United StatesSite Not Available
Rochester Clinical Research- Site Number : 8400005
Rochester 5134086, New York 5128638 14610
United StatesSite Not Available
Velocity Clinical Research - Providence- Site Number : 8400003
East Greenwich, Rhode Island 02818
United StatesSite Not Available
Velocity Clinical Research - Providence- Site Number : 8400003
East Greenwich 5221875, Rhode Island 5224323 02818
United StatesSite Not Available
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah 84109
United StatesSite Not Available
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City 5780993, Utah 5549030 84109
United StatesSite Not Available

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