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

Launched by SANOFI · Aug 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called vYF to see if it is safe and effective in helping young children’s bodies build protection against yellow fever. The study will compare this new vaccine to two already approved yellow fever vaccines and will also look at how well it works when given at the same time as the measles, mumps, and rubella (MMR) vaccine in babies aged 11 to 15 months.

Children between 9 months and 5 years old who are generally healthy may be eligible to join the study. For the group receiving both the vYF and MMR vaccines together, children need to be between 11 and 15 months old. If your child joins the study, they will receive one dose of either the new vaccine or one of the approved vaccines, and some children will be invited back after three years to receive a booster dose. The whole participation will last about three years, with extra follow-up for those getting the booster. Throughout the study, doctors will monitor your child’s health and immune response to the vaccines. This study is important because it helps researchers understand if the new vaccine works well and is safe for young children, especially when given alongside other routine childhood vaccines.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 9 months to 5 years on the day of inclusion\*
• • \* "9 months to 5 years" means from the day of the 9th month after birth to the day before the 6th year birthday
• • Aged 11 to 15 months\* on the day of inclusion for participants enrolled in the MMR co-administration group
• • \* "11 to 15 months" means from the day of the 11th month after birth to the day before the 16th month birthday
• • Participants who are healthy as determined by medical evaluation including medical history and physical examination
• • For infants\*, born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention
• • \* Infants aged 9 months to 11 months up to the day before the 12th month birthday
• • Participant and parent/LAR are able to attend all scheduled visits and to comply with all study procedures
• • ICF has been signed and dated by the parent(s) or other LAR (and by an independent witness if required by local regulations)
• 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