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

NCT05312294 | Completed Phase 3

• 1 other identifier: FLM-03-2020
• Study Type: interventional
• Target: 654
• Locations: 1 country
• Sites: 8

Brief 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

Conditions

Influenza; Flu, Human

Keywords

Influenza; Flu; Vaccine; FLU-M; SPbSRIVS

Outcome Measures

Primary Outcomes (2)

• Change from baseline geometric mean titer ratio of antibodies for each virus strain (GMT (Flu-M w/p) / GMT (Flu-M w/o/p) at 6 months

  The upper limit of bilateral 95% CI for the GMT ratio (GMT (Flu-M w/p) / GMT (Flu-M w/o/p) should not exceed 1.5

  days 0-180

• Change from baseline the difference between seroconversion rates (seroconversion rate Flu-M w/p - seroconversion rate Flu-M w/o/p) at 6 months

  The upper limit of bilateral 95% CI for the difference between seroconversion rates (seroconversion rate Flu-M w/p - seroconversion rate Flu-M w/o/p) should not exceed 10%

  days 0-180

Secondary Outcomes (15)

• Geometric mean titer of antibodies for each virus strain (A (H1N1), A (H3N2) and B)

  days 0,28,180

• Seroconversion rate for each virus strain (A (H1N1), A (H3N2) and B)

  days 0,28,180

• Seroconversion factor for each virus strain (A (H1N1), A (H3N2) and B)

  days 0,28,180

• Seroprotection rate for each virus strain (A (H1N1), A (H3N2) and B)

  days 0,28,180

• Incidence, severity, and duration of influenza or ARVI during 6 months after vaccination

  days 1-180

Study Arms (2)

FLU-M w/o/p

EXPERIMENTAL

Volunteers were vaccinated with a single dose of the Flu-M vaccine (without preservative) intramuscularly in a dose of 0.5 mL.

Biological: Flu-M [inactivated split influenza vaccine] without preservative

FLU-M w/p

EXPERIMENTAL

Volunteers were vaccinated with a single dose of the Flu-M vaccine (with preservative) intramuscularly in a dose of 0.5 mL.

Biological: Flu-M [inactivated split influenza vaccine] with preservative

Interventions

Flu-M [inactivated split influenza vaccine] without preservative BIOLOGICAL

Solution for intramuscular injection, 0.5 ml

FLU-M w/o/p

Flu-M [inactivated split influenza vaccine] with preservative BIOLOGICAL

Solution for intramuscular injection, 0.5 ml

FLU-M w/p

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers (men and women) aged 18-60 years;
• 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;
• Guillain-Barré syndrome (acute polyneuropathy) in the medical history;
• 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;
• Use of any vaccines within 1 month before the vaccination, excluding vaccines according to the National Calendar of Preventive Vaccination, including for epidemic reasons;
• 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 or immune systems, mental disease in the acute stage or in the decompensation stage (recovery less than 4 weeks before vaccination);
• Diabetes mellitus, thyrotoxicosis or other diseases of the endocrine system;

Sponsors & Collaborators

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

Study Sites (8)

State Autonomous Health Institution "Engels City Clinical Hospital No1"

Engel's, Russia

Location

Limited Liability Company "Professorskaya Clinica"

Perm, Russia

Location

Limited Liability Company "Clinika Zvezdnaya"

Saint Petersburg, Russia

Location

Limited Liability Company "MEDICINSKAYA CLINIKA"

Saint Petersburg, Russia

Location

Limited Liability Company "PeterClinic"

Saint Petersburg, Russia

Location

Limited Liability Company "Scientific Research Center Eco-Safety"

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

Limited Liability Company "Medical Center Diagnostics and Prevention Plus"

Yaroslavl, 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: March 17, 2022
• First Posted: April 5, 2022
• Study Start: December 7, 2020
• Primary Completion: September 3, 2021
• Study Completion: November 15, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-03

Locations

RU (8)