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NCT04142086 · ClinicalTrials.gov registry record · Phase 1
Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
NCT04142086: Completed Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT04142086 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 73 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04142086, a Phase 1 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
Study Summary
The primary objectives of the study are: * To describe the safety profile of each of the 3 dosages of vYF and of YF-VAX® within the 28 days post-vaccination and up to the 6 months (Day 180) post-vaccination visit * To describe the antibody responses elicited by each of the 3 dosages of vYF and by YF-VAX on Day 0 pre-vaccination and then on Day 10, Day 14, Day 28 and 6 months (Day 180) post-vaccination overall and by baseline flavivirus serostatus * To quantify the detectable yellow fever (YF) vaccinal viremia in each vaccine groups (vYF and YF-VAX) in a subset of subjects on Day 0 visit, Day 1 visit, Day 3 visit, Day 5 visit, Day 7 visit, Day 10 visit, and Day 14 visit.
Primary Outcome
Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
Interventions
- BIOLOGICAL Yellow fever vaccine
- BIOLOGICAL Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine
- BIOLOGICAL Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine
- BIOLOGICAL Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2020-01-15 |
| Est. Completion | 2021-06-24 |
| Phase | Phase 1 |
What the finished NCT04142086 record still lists
NCT04142086 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 4 interventions - of which Yellow fever vaccine is the first listed.
NCT04142086 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04142086 about?
NCT04142086 is a clinical study titled "Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults". The primary objectives of the study are: * To describe the safety profile of each of the 3 dosages of vYF and of YF-VAX® within the 28 days post-vaccination and up to the 6 months (Day 180) post-vaccination visit * To describe the antibody responses elicited by each of the 3 dosages of vYF and by Y...
What is the current status of trial NCT04142086?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2020-01-15. Estimated completion is 2021-06-24.
What interventions are being tested in trial NCT04142086?
The interventions under investigation include: Yellow fever vaccine (BIOLOGICAL), Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine (BIOLOGICAL), Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine (BIOLOGICAL), Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04142086?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04142086's enrollment target sits among peer trials
73 732nd of 2000 higher than 1,265 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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