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

Sanofi Pasteur0 sites690 target enrollmentJuly 23, 2021

ConditionsPrevention of yellow fever MedDRA version: 20.0Level: PTClassification code 10048240Term: Yellow feverSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsSTAMARIL

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prevention of yellow fever
Sponsor: Sanofi Pasteur
Enrollment: 690
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 23, 2021

End Date

TBD

Last Updated

last year

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.