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Phase 3 Single Arm, Open Study on vYF in Adults

NCT07222059 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2026-02-03

No results posted yet for this study

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.

Conditions

  • Yellow Fever

Interventions

BIOLOGICAL

Yellow fever vaccine (live)

Pharmaceutical form:Powder and diluent for suspension for injection-Route of administration:Subcutaneous

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07222059 on ClinicalTrials.gov