Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT05308212
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2022-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tolerability, Safety and Immunogenicity Trial of the FLU-M® Tetra
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® Tetra Inactivated Vaccine in Volunteers Aged 60 Years and Above
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® Tetra quadrivalent inactivated split influenza vaccine and the Ultrix® vaccine in volunteers aged 60 years and above.
Detailed Description:
Evaluation of the tolerability, safety and immunogenicity of the inactivated split influenza vaccine FLU-M® Tetra compared to Ultrix® vaccine in volunteers aged 60 years and above.
Volunteers were screened and randomized in three groups: the Flu-M Tetra w/p (with preservative) group, the Flu-M Tetra w/o/p (without preservative) group and the Ultrix® group. All subjects were followed up for 28 days post randomization and vaccination.
Volunteers were screened and randomized in three groups: the Flu-M Tetra w/p (with preservative) group, the Flu-M Tetra w/o/p (without preservative) group and the Ultrix® group. All subjects were followed up for 28 days post randomization and vaccination.
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?: