Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-08 @ 2:05 PM
Study NCT ID:
NCT07002060
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Randomized, Modified Double-blind, Active-controlled Safety Study on vYF in Adults
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Phase 3 Randomized, Modified Double-blind, Active-controlled Study to Assess the Safety of vYF, Yellow Fever Vaccine, in Adults Aged 18 Years up to 60 Years
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety of vYF (investigational vaccine) compared to the safety of YF-VAX (YF licensed vaccine) in adults aged 18 years up to 60 years.
Study details include:
* The study duration will be up to approximately 6 months.
* One single dose of the study intervention (vYF or YF-VAX) will be administered subcutaneously at the 1st visit.
* The visit(V) frequency will be Day(D) 01 (V01) and D29 (V02). Two telephone calls will be planned at D15 and Month(M)6.
Number of Participants:
A total of 640 participants are expected to be included in the study in a 3:1 ratio (vYF: YF-VAX):
Group 1: vYF; N=480 Group 2: YF-VAX; N=160
Study Arms and Duration:
Randomized, active control (YF-VAX). 6 months duration per participants. Eligible participants will be randomized in a 3:1 ratio to receive, subcutaneously, a single dose of vYF or YF-VAX vaccines on D01.
Study details include:
* The study duration will be up to approximately 6 months.
* One single dose of the study intervention (vYF or YF-VAX) will be administered subcutaneously at the 1st visit.
* The visit(V) frequency will be Day(D) 01 (V01) and D29 (V02). Two telephone calls will be planned at D15 and Month(M)6.
Number of Participants:
A total of 640 participants are expected to be included in the study in a 3:1 ratio (vYF: YF-VAX):
Group 1: vYF; N=480 Group 2: YF-VAX; N=160
Study Arms and Duration:
Randomized, active control (YF-VAX). 6 months duration per participants. Eligible participants will be randomized in a 3:1 ratio to receive, subcutaneously, a single dose of vYF or YF-VAX vaccines on D01.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: