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Study on an Investigational Yellow Fever Vaccine Compared With YF-VAX in Adults in the USA

NCT04942210 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 568

Last updated 2025-06-18

Study results available
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Summary

The primary objective of the study is to demonstrate the non-inferiority of the antibody response in terms of seroconversion rate 28 days after vaccine administration of one dose of yellow fever vaccine (vYF) compared to the antibody response after one dose of the YF-VAX control vaccine in yellow fever naïve participants.

The secondary objectives of the study are:

* To describe the immune response to yellow fever in both vaccine groups before and after vYF or YF-VAX administration.
* To describe the safety profile of vYF vaccine in comparison to the safety profile of the control YF-VAX.
* To describe the biosafety profile of vYF in comparison to the biosafety profile of the control YF-VAX.

Conditions

  • Yellow Fever
  • Healthy Volunteers

Interventions

BIOLOGICAL

Yellow fever vaccine (produced on serum-free Vero cells)

Powder and diluent for suspension for injection Subcutaneous injection

BIOLOGICAL

Yellow fever vaccine

Powder and diluent for suspension for injection Subcutaneous injection

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-06-24
Completion
2027-06-29
FDA Drug
Yes

Countries

  • United States

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 NCT04942210 on ClinicalTrials.gov