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

NCT05089123 | Completed Phase 3

• 1 other identifier: FM-2019-02
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Influenza

Keywords

influenza; flu; vaccine; Flu-M

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Flu-M

EXPERIMENTAL

160 volunteers were vaccinated with the Flu-M inactivated split influenza vaccine with a preservative

Biological: Flu-M [Inactivated split influenza vaccine]

Ultrix

ACTIVE COMPARATOR

160 volunteers were vaccinated with the Ultrix (Inactivated split influenza vaccine)

Biological: Inactivated Split Influenza Vaccine

Interventions

Flu-M [Inactivated split influenza vaccine] BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Flu-M

Inactivated Split Influenza Vaccine BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Ultrix

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

LLC "Meditsinskie Tehnologii"

Saint Petersburg, Russia

Location

LLC "Strategicheskie Meditsinskie Sistemi"

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 22, 2021
• Study Start: March 3, 2020
• Primary Completion: May 28, 2020
• Study Completion: August 24, 2020
• Last Updated: January 6, 2022

Record last verified: 2021-10

Locations

RU (2)