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

Study Overview
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Brief Summary
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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
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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: Screening period (up to 7 days): • Visit 0 (day -7...-1). Vaccination period (up to 1 day): • Visit 1 (day 1, randomization, blood collection for serological examination, vaccination). 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);

Official Title
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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

Conditions
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Influenza

Intervention / Treatment
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* Biological: Flu-M [Inactivated split influenza vaccine]
* Biological: Inactivated Split Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza, flu, vaccine, Flu-M