NCT05308212

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
633

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
Last Updated

November 8, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

March 15, 2022

Last Update Submit

November 3, 2022

Conditions

Influenza

Keywords

influenzafluvaccineFLU-M Tetra

Outcome Measures

Primary Outcomes (1)

  • Geometric mean titer (GMT) ratio of antibodies after vaccination

    Geometric mean titer (GMT) of antibodies in the blood serums of vaccinated people in haemagglutination inhibition assay.

    days 0, 28

Secondary Outcomes (16)

  • Change from baseline seroconversion rate at 28 days

    days 0, 28

  • Seroconversion factor

    days 0, 28

  • Seroprotection rate

    days 0, 28

  • Frequency of development of AEs associated with the vaccination

    days 0-28

  • Frequency of development of SAEs associated with the vaccination

    days 0-28

  • +11 more secondary outcomes

Study Arms (3)

FLU-M Tetra w/p

EXPERIMENTAL

211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Flu-M Tetra vaccine (with preservative) intramuscularly

Biological: Flu-M Tetra [Inactivated split influenza vaccine] w/p

FLU-M Tetra w/o/p

EXPERIMENTAL

211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Flu-M Tetra vaccine (without preservative) intramuscularly.

Biological: Flu-M Tetra [Inactivated split influenza vaccine] w/o/p

Ultrix

ACTIVE COMPARATOR

211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Ultrix vaccine.

Biological: Ultrix [Inactivated split influenza vaccine]

Interventions

Flu-M Tetra [Inactivated split influenza vaccine] w/pBIOLOGICAL

solution for intramuscular injection, 0.5 ml

FLU-M Tetra w/p
Flu-M Tetra [Inactivated split influenza vaccine] w/o/pBIOLOGICAL

solution for intramuscular injection, 0.5 ml

FLU-M Tetra w/o/p
Ultrix [Inactivated split influenza vaccine]BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Ultrix

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers (men and women) at the age of 60 years and above
  • Written informed consent of volunteers to participate in the clinical trial;
  • Volunteers able to fulfill requirements of the Protocol (i.e. fill out the patient's diary, come to follow-up visits);
  • For fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception during the trial and at least two months after vaccination;
  • For fertile men - consent to observe adequate methods of contraception during the trial and at least two months after vaccination, except for men after vasectomy with documented azoospermia, and their sexual partners should use methods of contraception that ensure more than 90% reliability or be incapable of conception after a surgical sterilization or have a natural menopause for at least 2 years.

You may not qualify if:

  • History of influenza/ARVI or previous influenza vaccination during 6 months before the trial;
  • Positive result of the SARS-CoV-2 test;
  • A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) or complications (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination);
  • Allergic reactions to vaccine components or any previous vaccination;
  • History of allergic reaction to chicken protein;
  • History of Guillain-Barré syndrome (acute polyneuropathy);
  • Previous vaccination with rabies vaccines less than 2 months before immunization or scheduled vaccination with rabies vaccines within 1 month after immunization with the trial vaccines;
  • History of leukemia, cancer, autoimmune diseases;
  • Positive blood test results for HIV, syphilis, hepatitis B/C.
  • Volunteers who received immunoglobulin or blood products or had a blood transfusion during the last three months before the trial;
  • History of long-term use (more than 14 days) of immunosuppressants or immunomodulatory drugs for six months before the trial;
  • History of any confirmed or suspected immunosuppressive or immunodeficiency condition;
  • History of chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, the gastrointestinal tract, liver, kidneys, hematopoietic, immune and endocrine system, mental disease in the acute stage or in the decompensation stage (recovery less than 4 weeks before vaccination);
  • History of eczema;
  • Treatment with glucocorticosteroids, including in small doses, as well as local use of drugs containing steroids (\> 10 mg of prednisolone or its equivalent for more than 14 days before the screening);
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

State Autonomous Health Institution "Engels City Clinical Hospital No1"

Engel's, Russia

Location

Limited Liability Company Professorskaya Clinica

Perm, Russia

Location

Limited Liability Company Energia Zdorovya

Saint Petersburg, Russia

Location

Limited Liability Company MEDICINSKAYA CLINIKA

Saint Petersburg, Russia

Location

Limited Liability Company Scientific Research Center Eco-Bezopasnost

Saint Petersburg, Russia

Location

Piramida Limited Liability Company

Saint Petersburg, Russia

Location

Private Health Care Institution Clinical Hospital "RZD-Medicine" in Saint Petersburg

Saint Petersburg, Russia

Location

Saint Petersburg State Budgetary Healthcare Institution "State Polyclinic No. 117"

Saint Petersburg, Russia

Location

Saint Petersburg State Budgetary Healthcare Institution "State Polyclinic No. 43"

Saint Petersburg, Russia

Location

Limited Liability Company "DNA Research Center"

Saratov, Russia

Location

Federal State Budget Healthcare Institution "Yaroslavl Region Clinical Hospital No. 2"

Yaroslavl, Russia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
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

March 15, 2022

First Posted

April 4, 2022

Study Start

March 4, 2021

Primary Completion

July 30, 2021

Study Completion

September 6, 2021

Last Updated

November 8, 2022

Record last verified: 2022-03

Locations

RU(11)