drugset / Trial / NCT07222059

Phase 3 Single Arm, Open Study on vYF in Adults

NCT07222059

Phase 3 Completed 254 enrolled Sanofi Pasteur, a Sanofi Company
NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2025-10-23
Primary completion
2025-12-25
Completion
2025-12-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Yellow fever vaccine (live) Vaccine Subcutaneous

Indications