NCT05308212

Tolerability, Safety and Immunogenicity Trial of the FLU-M® Tetra

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 633 (actual)
• Sponsor: St. Petersburg Research Institute of Vaccines and Sera · Other Government
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Flu-M Tetra [Inactivated split influenza vaccine] w/p	solution for intramuscular injection, 0.5 ml
BIOLOGICAL	Flu-M Tetra [Inactivated split influenza vaccine] w/o/p	solution for intramuscular injection, 0.5 ml
BIOLOGICAL	Ultrix [Inactivated split influenza vaccine]	solution for intramuscular injection, 0.5 ml

Timeline

• Start date: 2021-03-04
• Primary completion: 2021-07-30
• Completion: 2021-09-06
• First posted: 2022-04-04
• Last updated: 2022-11-08

Locations

11 sites across 1 country: Russia