NCT04142086

Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults

Safety, Tolerability, and Immunogenicity Dose-ranging Study of the Investigational Yellow Fever Vacine (vYF) Candidate Vaccine in Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of the study are: * To describe the safety profile of each of the 3 dosages of vYF and of YF-VAX® within the 28 days post-vaccination and up to the 6 months (Day 180) post-vaccination visit * To describe the antibody responses elicited by each of the 3 dosages of vYF and by YF-VAX on Day 0 pre-vaccination and then on Day 10, Day 14, Day 28 and 6 months (Day 180) post-vaccination overall and by baseline flavivirus serostatus * To quantify the detectable yellow fever (YF) vaccinal viremia in each vaccine groups (vYF and YF-VAX) in a subset of subjects on Day 0 visit, Day 1 visit, Day 3 visit, Day 5 visit, Day 7 visit, Day 10 visit, and Day 14 visit.

Detailed description

Study duration per participant is approximately 6 months.

Conditions

• Yellow Fever (Healthy Volunteers)

Interventions

Type	Name	Description
BIOLOGICAL	Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine	Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
BIOLOGICAL	Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine	Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
BIOLOGICAL	Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine	Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
BIOLOGICAL	Yellow fever vaccine	Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous

Timeline

• Start date: 2020-01-15
• Primary completion: 2021-06-24
• Completion: 2021-06-24
• First posted: 2019-10-29
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study