Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to Stamaril® in Adults

Sanofi Pasteur0 sites690 target enrollmentAugust 11, 2021

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 11, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Sanofi Pasteur

Eligibility Criteria

Inclusion Criteria

•\-Aged 18 years up 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.
•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 female 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 the test will be repeated on D29 to confirm the participant is still not pregnant within 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
•For participants enrolled in Asian countries as part of the additional cohort only: know Chinese origin, defined as having at least one biological parent of Chinese origin, and will be self\-reported by the participant
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•. Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the first 2 years of the 5\-year follow\-up in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Enrollment in another study after the first 2 years is permitted, assuming that it does not exclude participation in this study.
•. 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 4\), except for influenza vaccination, which may be received at least 2 weeks before study vaccines. This exception includes all influenza vaccines including monovalent pandemic influenza vaccines.
•. Previous vaccination against a FV disease at any time including YF with either the study 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 any FV infection.
•. Known systemic hypersensitivity to any of the vaccine components, eggs, or history of a life\-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
•. Known history or laboratory evidence of HIV infection.
•. Known history or laboratory evidence of hepatitis B or hepatitis C infection.