NCT07222059

Phase 3 Single Arm, Open Study on vYF in Adults

A Phase 3, Single Arm, Open Study to Assess the Immunogenicity and Safety of vYF in Adults Aged 18 Years and Over

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and immunogenicity of vYF in adults aged 18 years and over in Japan. Study details include: * The study duration will be up to approximately 1 month. * One single dose of vYF will be administrated subcutaneously at the 1st visit. * The visit frequency will be Day 01 (Visit 01) and Day 29 (Visit 02). One telephone call (TC) will be planned at Day 15. Number of Participants: A total of 254 participants is expected to be included in the study with the aim to obtain a total of 203 evaluable participants. Study Arms and Duration: Eligible participants will receive, subcutaneously, a single dose of vYF vaccine on Day 1. The duration of each participation will be approximately 1 month for each participant.

Detailed description

Duration of study participation: approximately 1 month for each participant

Conditions

• Yellow Fever

Interventions

Type	Name	Description
BIOLOGICAL	Yellow fever vaccine (live)	Pharmaceutical form:Powder and diluent for suspension for injection-Route of administration:Subcutaneous

Timeline

• Start date: 2025-10-23
• Primary completion: 2025-12-25
• Completion: 2025-12-25
• First posted: 2025-10-29
• Last updated: 2026-02-03

Locations

4 sites across 1 country: Japan