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

Sanofi Pasteur0 sites690 target enrollmentApril 7, 2021

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 7, 2021

End Date

TBD

Last Updated

2 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 (1\) or abstinence (1\) from at least 4 weeks prior to study intervention administration until at least 4 weeks (2\) after study intervention administration.
•\*18 to 60 years means from the day of the 18th birthday up to the day before the 60th birthday
•(1\) Not applicable for Finland
•(2\) Except for French participants which have to apply 12 weeks contraception after study intervention administration
•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 (3\)
•(3\) For participants aged less than 21 years in Singapore, an informed consent form has been signed and dated by both the participant and the parent(s) or another legally acceptable representative

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 (4\). 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 (5\).
•. Known history or laboratory evidence of hepatitis B or hepatitis C infection (6\).