NCT05089123

The Objectives of This Study Are Study the Immunogenicity and Safety of the Flu-M [Inactivated Split Influenza Vaccine], vs. the Ultrix® Inactivated Split Influenza Vaccine, in Volunteers Who Are Over 60 Years Old

Prospective, Multicenter, Double-blind, Randomized, Comparative Immunogenicity and Safety Trial of Flu-M [Inactivated Split Influenza Vaccine], Solution for Intramuscular Injection, 0.5 ml (FSUE SPbSRIVS FMBA), vs. Ultrix®, Solution for Intramuscular Injection, 0.5 ml (FORT LLC) in Volunteers Aged Over 60 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: St. Petersburg Research Institute of Vaccines and Sera · Other Government
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This trial by its design was a prospective, multicenter, double blind, randomized comparative clinical trial of the IIIb-IV phase which was carried out in parallel groups of volunteers over the age of 60

Detailed description

The volunteers will include in the trial will divide into two groups: Group 1: volunteers who will receive one dose of Flu-M, solution for intramuscular injection, 0.5 mL, intramuscularly. Group 2: volunteers who will receive one dose of Ultrix®, solution for intramuscular administration, 0.5 mL, intramuscularly. The trial include the following periods and visits: 1. Screening period (up to 7 days): • Visit 0 (day -7...-1). 2. Vaccination period (up to 1 day): • Visit 1 (day 1, randomization, blood collection for serological examination, vaccination). 3. Follow-up period (up to 28(+2) days): * Visit 2 (day 3, organization of trials to assess safety); * Visit 3 (day 7(+1), organization of trials to assess safety); * Visit 4 (day 21(+2), organization of trials to assess safety, blood collection for serological study); * Visit 5 (day 28(+2), organization of trials to assess safety, trial completion);

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Flu-M [Inactivated split influenza vaccine]	solution for intramuscular injection, 0.5 ml
BIOLOGICAL	Inactivated Split Influenza Vaccine	solution for intramuscular injection, 0.5 ml

Timeline

• Start date: 2020-03-03
• Primary completion: 2020-05-28
• Completion: 2020-08-24
• First posted: 2021-10-22
• Last updated: 2022-01-06

Locations

2 sites across 1 country: Russia