NCT05312294

Tolerability, Safety and Immunogenicity Trial of the Flu-M® Inactivated Vaccine in Volunteers Aged 18 to 60 Years

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 654 (actual)
• Sponsor: St. Petersburg Research Institute of Vaccines and Sera · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza
• Flu, Human

Interventions

Type	Name	Description
BIOLOGICAL	Flu-M [inactivated split influenza vaccine] without preservative	Solution for intramuscular injection, 0.5 ml
BIOLOGICAL	Flu-M [inactivated split influenza vaccine] with preservative	Solution for intramuscular injection, 0.5 ml

Timeline

• Start date: 2020-12-07
• Primary completion: 2021-09-03
• Completion: 2021-11-15
• First posted: 2022-04-05
• Last updated: 2022-04-05

Locations

8 sites across 1 country: Russia