Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to YF-VAX in Adults

Who is this study for? Patients with Yellow Fever
What treatments are being studied? Yellow Fever Vaccine (Produced on Serum-free Vero Cells)
Status: Active, not recruiting
Location: See all (11) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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.

Locations
United States
Georgia
Emory University Decatur-Site Number:8400005
Decatur
Louisiana
MedPharmics-Site Number:8400008
Metairie
Massachusetts
Harvard University Medical School-Site Number:8400002
Boston
Maryland
Johns Hopkins Bloomberg School of Public Health (JHSPH)-Site Number:8400004
Baltimore
Missouri
Saint Louis University-Site Number:8400003
Saint Louis
Nebraska
Meridian Clinical Research-Site Number:8400009
Omaha
New York
NYU Langone Vaccine Center-Site Number:8400013
New York
Rochester Clinical Research, Inc.-Site Number:8400010
Rochester
SUNY Upstate Medical University-Site Number:8400006
Syracuse
Rhode Island
Velocity Clinical Research - Providence-Site Number:8400015
East Greenwich
Utah
J Lewis Research Inc-Site Number:8400012
Salt Lake City
Time Frame
Start Date: July 1, 2021
Estimated Completion Date: January 31, 2027
Participants
Target number of participants: 567
Treatments
Experimental: vYF
1 injection of vYF at Day 1
Active Comparator: YF-VAX
1 injection of YF-VAX at Day 1
Related Therapeutic Areas
Sponsors
Leads: Sanofi Pasteur, a Sanofi Company

This content was sourced from clinicaltrials.gov

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