Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to YF-VAX in Adults
The primary objective of the study is to demonstrate the non-inferiority of the antibody response in terms of seroconversion rate 28 days after vaccine administration of one dose of yellow fever vaccine (vYF) compared to the antibody response after one dose of the YF-VAX control vaccine in yellow fever naïve participants. The secondary objectives of the study are: To describe the immune response to yellow fever in both vaccine groups before and after vYF or YF-VAX administration. To describe the safety profile of vYF vaccine in comparison to the safety profile of the control YF-VAX. To describe the biosafety profile of vYF in comparison to the biosafety profile of the control YF-VAX.
• Aged 18 years to 60 years on the day of inclusion.
• A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
• Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.
• OR Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) before any dose of study intervention on Day 1 and will be repeated on Day 29 to confirm the participant is still not pregnant within the 28 days of vaccine administration.
• Informed consent form has been signed and dated.
• Able to attend all scheduled visits and to comply with all study procedures.