Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-25 @ 11:00 PM
Study NCT ID:
NCT07222059
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Single Arm, Open Study on vYF in Adults
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
A Phase 3, Single Arm, Open Study to Assess the Immunogenicity and Safety of vYF in Adults Aged 18 Years and Over
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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 and immunogenicity of vYF in adults aged 18 years and over in Japan.
Study details include:
* The study duration will be up to approximately 1 month.
* One single dose of vYF will be administrated subcutaneously at the 1st visit.
* The visit frequency will be Day 01 (Visit 01) and Day 29 (Visit 02). One telephone call (TC) will be planned at Day 15.
Number of Participants:
A total of 254 participants is expected to be included in the study with the aim to obtain a total of 203 evaluable participants.
Study Arms and Duration:
Eligible participants will receive, subcutaneously, a single dose of vYF vaccine on Day 1.
The duration of each participation will be approximately 1 month for each participant.
Study details include:
* The study duration will be up to approximately 1 month.
* One single dose of vYF will be administrated subcutaneously at the 1st visit.
* The visit frequency will be Day 01 (Visit 01) and Day 29 (Visit 02). One telephone call (TC) will be planned at Day 15.
Number of Participants:
A total of 254 participants is expected to be included in the study with the aim to obtain a total of 203 evaluable participants.
Study Arms and Duration:
Eligible participants will receive, subcutaneously, a single dose of vYF vaccine on Day 1.
The duration of each participation will be approximately 1 month for each participant.
Detailed Description:
Duration of study participation: approximately 1 month for each participant
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| VYF00011 | OTHER | Sanofi Identifier | View |