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

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

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Flu-M [Inactivated split influenza vaccine]; Biological: Inactivated Split Influenza Vaccine

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);

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation
    • LLC "Meditsinskie Tehnologii"
  • Saint Petersburg, Russian Federation
    • LLC "Strategicheskie Meditsinskie Sistemi"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of signed informed consent to participate in the trial.
• Volunteers (both male and female) over the age of 60 who could meet the Protocol requirements.
• Negative pregnancy test obtained from female volunteers with preserved childbearing potential.
• Consent to use adequate contraception methods (contraception methods with degree of reliability of more than 90%: a nonhormonal intrauterine device; a spermicide condom; a spermicide cervical cap; spermicide diaphragms) or total sexual abstinence during the clinical trial (until Visit 5 (day 28(+2)).

Exclusion Criteria:

• Allergic reactions to chicken protein or any previous influenza vaccination.
• Anamnestic data on the episodes of severe allergic reactions and/or diseases (anaphylaxis, Quincke's edema, polymorphic exudative erythema, serum disease etc.)
• Acute reaction (temperature above 38.5оС, edema and hyperemia over 5 cm in diameter at the injection site) or complications caused by previous administration of the drug.
• Previous vaccination 6 months before the start of the trial.
• History of leucosis, blood cancer, malignant oncological diseases.
• Guillain-Barré syndrome (acute polyneuropathy) in the medical history.
• Positive screening for HIV infection, B and C hepatitis, syphilis.
• Any confirmed or suspected immunosuppressive or immunodeficiency condition;
• Administration of immunoglobulin or blood products within the last three months before the study.
• Long-term use (more than 14 days) of immunosuppressants (including systemic corticosteroids, cytotoxic, radioactive preparations) or other immunomodulatory drugs for six months before the trial.
• Chronic diseases at the decompensation stage or in debilitating form, which can make it dangerous for the volunteer to take part in the trial.
• Progressive neurological disorders, dementia.
• Blood disorders which serve as a contradiction for intramuscular injection.
• History of alcohol or drug addiction.
• Pregnancy, breastfeeding in women with preserved reproductive performance.
• Current participation in another clinical trial or within the previous 3 months before the screening.
• Mental, physical and other problems which do not allow for appropriate assessment of own behavior and following the requirements set out in the trial protocol.
• Any other conditions which in the reasonable opinion of the clinical investigator complicate the participation of the volunteer in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flu-M; 160 volunteers were vaccinated with the Flu-M inactivated split influenza vaccine with a preservative	Biological: Flu-M [Inactivated split influenza vaccine]; solution for intramuscular injection, 0.5 ml
Active Comparator: Ultrix; 160 volunteers were vaccinated with the Ultrix (Inactivated split influenza vaccine)	Biological: Inactivated Split Influenza Vaccine; solution for intramuscular injection, 0.5 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity assessment	Seroconversion rate defined as the percentage of subjects who have a pre-vaccination titer of influenza haemagglutinin antibody titer (HA titer) < 1:10 and a post-vaccination HA titer >1:40 or a pre-vaccination HA titer > 1:10 and at least a fourfold increase in post-vaccination HA titer vs. the baseline for each strain (A/H1N1, A/H3N2 and B)	21 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The percentage of subjects with protective titer of antibodies ≥ 1:40 on the 21(+2) day after the vaccination for each strain (A/H1N1, A/H3N2 and B).	21 days
Increasing of geometric mean titer on the 21(+2) day against the value observed before the use of vaccine for each strain (A/H1N1, A/H3N2 and B)	21 days
The percentage of volunteers with a pre-vaccination HA titer <1:10 and a post-vaccination HA titer >1:40 or a pre-vaccination HA titer > 1:10 and at least a fourfold increase in a post-vaccination HA titer vs. the baseline should be > 30%	21 days
Increasing of geometric mean titer in > 2.0 times	21 days
The percentage with protective antibody titer ≥ 1:40	21 days

Collaborators and Investigators

• Sponsor: St. Petersburg Research Institute of Vaccines and Sera

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Actual): May 28, 2020
• Study Completion (Actual): August 24, 2020

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: vaccine; influenza; flu; Flu-M
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: FM-2019-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No