MedTrace Logo

Phase 3 Randomized, Modified Double-blind, Active-controlled Safety Study on vYF in Adults

NCT07002060 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2026-02-02

No results posted yet for this study

Summary

The purpose of this study is to assess the safety of vYF (investigational vaccine) compared to the safety of YF-VAX (YF licensed vaccine) in adults aged 18 years up to 60 years.

Study details include:

* The study duration will be up to approximately 6 months.
* One single dose of the study intervention (vYF or YF-VAX) will be administered subcutaneously at the 1st visit.
* The visit(V) frequency will be Day(D) 01 (V01) and D29 (V02). Two telephone calls will be planned at D15 and Month(M)6.

Number of Participants:

A total of 640 participants are expected to be included in the study in a 3:1 ratio (vYF: YF-VAX):

Group 1: vYF; N=480 Group 2: YF-VAX; N=160

Study Arms and Duration:

Randomized, active control (YF-VAX). 6 months duration per participants. Eligible participants will be randomized in a 3:1 ratio to receive, subcutaneously, a single dose of vYF or YF-VAX vaccines on D01.

Conditions

  • Yellow Fever Immunization

Interventions

BIOLOGICAL

Yellow fever vaccine (live)

Powder and solvent for solution for injection Subcutaneous

BIOLOGICAL

YF vaccine (live)

Powder and diluent for suspension for injection Subcutaneous

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-22
Primary Completion
2026-01-20
Completion
2026-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT07002060 on ClinicalTrials.gov