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Virus Vaccine

Investigational Yellow Fever Vaccine vs Standard Vaccine for Yellow Fever (VYF02 Trial)

Phase 2
Waitlist Available
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.
Aged 18 years to 60 years on the day of inclusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 11, day 29, month 6, year 1, year 2, year 3, year 4, and year 5
Awards & highlights

VYF02 Trial Summary

This trial is testing a new yellow fever vaccine against the standard yellow fever vaccine to see if it is non-inferior in terms of antibody response. The study will also compare the safety and biosafety profiles of the two vaccines.

Who is the study for?
Adults aged 18-60 in the USA who've never had yellow fever or a vaccine against it can join. Women must not be pregnant/breastfeeding, use contraception, and have negative pregnancy tests before/during the study. Participants should be free of certain infections, immune conditions, and not taking specific medications.Check my eligibility
What is being tested?
The trial is testing a new yellow fever vaccine made with Vero cells against the standard YF-VAX. It measures if people's bodies respond similarly to both vaccines by looking at antibodies after 28 days and monitors safety over time.See study design
What are the potential side effects?
Potential side effects aren't detailed here but will compare how participants react to each vaccine regarding general health disturbances that could include typical vaccine reactions like soreness, redness at injection site, fever or allergic responses.

VYF02 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not able to have children because I am postmenopausal for over a year or have been surgically sterilized.
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I am between 18 and 60 years old.
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I am not pregnant or breastfeeding, and I cannot have children due to menopause or surgery.
Select...
I am between 18 and 60 years old.

VYF02 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 months after vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 months after vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants with seroconversion to YF virus at Day 29
Secondary outcome measures
Number of participants with adverse events of special interest
Number of participants with immediate adverse events
Number of participants with out-of-range biochemistry and hematology test results
+7 more

VYF02 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: vYFExperimental Treatment1 Intervention
1 injection of vYF at Day 1
Group II: YF-VAXActive Control1 Intervention
1 injection of YF-VAX at Day 1

Find a Location

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
407 Previous Clinical Trials
6,091,414 Total Patients Enrolled
7 Trials studying Yellow Fever
2,695 Patients Enrolled for Yellow Fever
Clinical Sciences & OperationsStudy DirectorSanofi Pasteur, a Sanofi Company
857 Previous Clinical Trials
2,018,732 Total Patients Enrolled
2 Trials studying Yellow Fever
763 Patients Enrolled for Yellow Fever

Media Library

Yellow fever vaccine (produced on serum-free Vero cells) (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04942210 — Phase 2
Yellow Fever Research Study Groups: vYF, YF-VAX
Yellow Fever Clinical Trial 2023: Yellow fever vaccine (produced on serum-free Vero cells) Highlights & Side Effects. Trial Name: NCT04942210 — Phase 2
Yellow fever vaccine (produced on serum-free Vero cells) (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04942210 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people over the age of 45 participate in this series of tests?

"The age limit for this particular clinical trial is 60 years old. However, if you are under 18 or over 65 there may be other trials more suited for you as respectively there 26 and 75 trials designed around those age brackets."

Answered by AI

How many people are included in this experiment at most?

"Unfortunately, this trial is no longer recruiting patients. The study was posted on July 1st, 2021 and last updated on October 5th, 2022. However, there are 103 other trials for fever and 7 for Yellow fever vaccine (produced on serum-free Vero cells) that are still searching for participants."

Answered by AI

Are there previous examples of Vero cell-derived yellow fever vaccines being tested on humans?

"There are seven ongoing clinical trials testing the efficacy of Yellow fever vaccines produced on serum-free Vero cells. Of these, none have advanced to Phase 3 yet. Most of the trial locations are in Madrid, but there are 59 sites total running these tests."

Answered by AI

Are there any available positions for test subjects in this experiment?

"This study is no longer looking for new participants. The trial was initially posted on July 1st, 2021 and was last updated on October 5th, 2022. Currently, there are 103 other trials searching for patients with fever and 7 studies exploring the Yellow fever vaccine (produced on serum-free Vero cells) that are actively enrolling patients."

Answered by AI

What is the FDA's opinion on Yellow fever vaccine (produced on serum-free Vero cells)?

"While there is some data supporting the safety of Yellow fever vaccine (produced on serum-free Vero cells), it received a score of 2 because there is no clinical evidence yet to suggest that it is an effective treatment."

Answered by AI

In how many different medical clinics is this trial being conducted?

"Currently, there are 23 hospitals and research centres enrolling patients for this clinical trial. If you choose to participate in the study, try to select a location that is nearest to you to reduce travel time and expenses."

Answered by AI

Could I possibly join this clinical study?

"This study is looking for 567 patients within the ages of 18 and 60 who currently have a fever. The following are required criteria that patients must meet: Aged 18 years to 60 years on the day of inclusion, OR Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) before any dose of study intervention on Day 1 and will be repeated on Day 29 to confirm the participant is still not pregnant within"

Answered by AI

Who else is applying?

What state do they live in?
Utah
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study on an Investigational Yellow Fever Vaccine Compared With YF-VAX in Adults in the USA
2021. "Study on an Investigational Yellow Fever Vaccine Compared With YF-VAX in Adults in the USA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04942210.
~151 spots leftby Apr 2025
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