Phase 3 Randomized, Modified Double-blind, Active-controlled Safety Study on vYF in Adults

Exclusion Criteria

• •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive 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 3 months)
• •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, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine 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 it might interfere with trial conduct or completion , including malignancy, such as leukemia or lymphoma
• •Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38°C \[or ≥ 100.4°F\]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
• •Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
• •Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination (prior to Visit 2 on D29), except for influenza vaccination, which may be received at least 2 weeks before study vaccine. This exception includes pandemic influenza vaccines including 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 to the 6 weeks following the vaccination
• •Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the course of the study in another clinical 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 with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
• •Planned travel in a YF endemic country within 6 months of investigational vaccine administration