Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-02-08 @ 5:48 AM
Study NCT ID:
NCT05312294
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2022-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability, Safety and Immunogenicity Trial of the Flu-M® Inactivated Vaccine in Volunteers Aged 18 to 60 Years
Sponsor:
St. Petersburg Research Institute of Vaccines and Sera
Organization:
Study Overview
Official Title:
Multicenter, Double-blind, Comparative, Randomized Tolerability, Safety and Immunogenicity Trial of the Flu-M® Inactivated Vaccine in Volunteers Aged 18 to 60 Years
Status:
COMPLETED
Status Verified Date:
2022-03
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:
Comparative assessment of the tolerability, safety, and immunogenicity of the Flu-M® Inactivated Split Influenza Vaccine (without preservative) and the Flu-M® vaccine (with preservative) in volunteers aged between 18 and 60
Detailed Description:
1. Assessment of the tolerability and safety of the Flu-M® inactivated split influenza vaccine (without preservative) and Flu-M® (with preservative).
2. Assessment of the immunogenicity of the Flu-M® inactivated split influenza vaccine (with preservative) and Flu-M® (without preservative).
Single administration of the trial products. Duration of follow-up - 28+3 (outpatient visit) and Long-term follow-up - 180±3 days.
2. Assessment of the immunogenicity of the Flu-M® inactivated split influenza vaccine (with preservative) and Flu-M® (without preservative).
Single administration of the trial products. Duration of follow-up - 28+3 (outpatient visit) and Long-term follow-up - 180±3 days.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: