A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population

Exclusion Criteria

• •Participants are excluded from the study if any of the following criteria apply:
• •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy irradiation 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 FV infection
• •Known systemic hypersensitivity to any of the study intervention components, eggs or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
• •Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
• •Chronic illness\* that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion , including malignancy, such as leukemia, or lymphoma
• •\*Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders or chronic infection
• •History of central nervous system disorder or disease, including seizures and febrile seizures
• •Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration. Vaccine to be administered as part of the National Immunization Schedule will be postponed after the D29 visit
• •Previous vaccination against a FV disease at any time including 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 study intervention administration and up to the 6 weeks following the study intervention administration
• •For participants enrolled in the MMR co-administration group: previous vaccination against measles, measles/mumps/rubella
• •For participants enrolled in the MMR co-administration group: history of measles, mumps, rubella confirmed either clinically, serologically, or microbiologically
• •Known history or laboratory evidence of HIV infection
• •Known history of hepatitis B or hepatitis C seropositivity
• •Personal or family history of thymic pathology (thymoma, thymectomy, or myasthenia)
• •Participation at the time of study enrollment (or in the 4 weeks preceding the study intervention administration) or planned participation during the first year of the 3-year follow-up in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Enrollment in another study after the first 6 months of follow-up is permitted, assuming it does not exclude participation in this study.
• •In an emergency setting, or hospitalized involuntary
• •Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study