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NCT04942210 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Healthy Volunteers and Yellow Fever, sponsored by Sanofi Pasteur, a Sanofi Company.

Active
Registry status
Phase 2
Development phase
568
Enrollment target
11
Study locations

NCT04942210 is a Phase 2 study of Healthy Volunteers and Yellow Fever that is active but no longer recruiting, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 568 participants, above the 480-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (18% higher). The trial reports 11 study locations across 9 states.

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The verdict

NCT04942210, a Phase 2 study of Healthy Volunteers and Yellow Fever, is active but no longer recruiting, sponsored by Sanofi Pasteur, a Sanofi Company.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
568 participants
Enrollment target
11
Study locations

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.

Conditions Studied

Healthy Volunteers Yellow Fever

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

153 total trials

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What the Registry Record Tells You About NCT04942210

The ClinicalTrials.gov registry entry for NCT04942210 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 568 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 480-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (18% higher). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.

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.

NCT04942210 reports 11 study locations spanning 9 distinct geographic areas - top geographies include New York, Georgia, Louisiana.

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.

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).

Who is sponsoring clinical trial NCT04942210?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.