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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: Active Phase 2 study of Healthy Volunteers and Yellow Fever, sponsored by Sanofi Pasteur, a Sanofi Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Seroconversion was defined as a 4-fold increase in Nab titers as compared to the pre-vaccination value. YF-naive participants (or negative) at baseline corresponded to participants with no detectable YF antibody (Ab) titers before vaccination. The YF NAb titers were determined using a validated live virus microneutralization (MN) assay. Percentages are rounded off to the tenth decimal place.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 568 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2027-06-29 |
| Phase | Phase 2 |
What the registry record for NCT04942210 still lists
NCT04942210 is an interventional study that assigns participants to a tested intervention. The registered 568 participants enrollment target is mid-sized for trials with a published cap, above the 480-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (18% higher).
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 lists 11 locations in 9 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04942210's enrollment target sits among peer trials
568 28th of 283 higher than 256 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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