Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults (VYF01)

This is an interventional prevention trial for Yellow Fever (Healthy Volunteers) Read More

Inclusion criteria :

• Aged 18 years up to 60 years on the day of inclusion
• Able to read and understand the Informed Consent Form which has been signed and dated
• Able to attend all scheduled visits and to comply with all trial procedures

Exclusion criteria:

• Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche , or post-menopausal for at least 1 year, or surgically sterile
• Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination
• Previous vaccination against a flavivirus disease including YF with either the trial vaccine or another vaccine
• Receipt of immune globulins, blood, or blood-derived products in the past 6 months
• 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 flavivirus infection
• Known systemic hypersensitivity to any of the vaccine components, eggs, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
• Known history or laboratory evidence of human immunodeficiency virus infection
• Known history of hepatitis B or hepatitis C seropositivity
• Personal of family history of thymic pathology (thymoma, thymectomy, or myasthenia)
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Current alcohol abuse or drug addiction
• 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 ≥ 100.4 F). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
• Administration of any anti-viral within 2 months preceding the vaccination and up to the 6 weeks following the vaccination
• 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 or control vaccine administration

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.