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ACTIVE NOT RECRUITING Phase 2

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

NCT04942210 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

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

Study Locations (11)

New York

  • SUNY Upstate Medical University Global Health Institute Site Number : 8400006 — East Syracuse
  • New York University Langone Medical Center Site Number : 8400013 — New York
  • Rochester Clinical Research, Inc.- Site Number : 8400010 — Rochester

Georgia

  • Emory University Decatur- Site Number : 8400005 — Decatur

Louisiana

  • Velocity Clinical Research- New Orleans Site Number : 8400008 — New Orleans

Maryland

  • Johns Hopkins Bloomberg School of Public Health (JHSPH)- Site Number : 8400004 — Baltimore

Massachusetts

  • Harvard University Medical School- Site Number : 8400002 — Boston

Missouri

  • Saint Louis University- Site Number : 8400003 — St Louis

Nebraska

  • Meridian Clinical Research- Site Number : 8400009 — Omaha

Rhode Island

  • Velocity Clinical Research - Providence Site Number : 8400015 — East Greenwich

Trial Details

FieldValue
Enrollment Target 568 participants
Start Date 2021-07-01
Est. Completion 2027-06-29
Phase Phase 2

Sponsor

Sanofi Pasteur, a Sanofi Company

43 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04942210

The ClinicalTrials.gov registry entry for NCT04942210 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 568 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions — of which Yellow fever vaccine (produced on serum-free Vero cells) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04942210 reports 11 study locations spanning 9 distinct geographic areas — top geographies include New York, Georgia, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04942210 about?

NCT04942210 is a clinical study titled "Study on an Investigational Yellow Fever Vaccine Compared With YF-VAX in Adults in the USA". 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 fe...

What is the current status of trial NCT04942210?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 568 participants. The study started on 2021-07-01. Estimated completion is 2027-06-29.

What conditions does trial NCT04942210 study?

This clinical trial studies the following conditions: Healthy Volunteers, Yellow Fever. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04942210?

The interventions under investigation include: Yellow fever vaccine (produced on serum-free Vero cells) (BIOLOGICAL), Yellow fever vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04942210?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04942210 being conducted?

This trial has 11 study locations across Georgia, Louisiana, Maryland, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial