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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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Flu-M [Inactivated split influenza vaccine]
Inactivated Split Influenza Vaccine
Sponsored by
St. Petersburg Research Institute of Vaccines and Sera
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring influenza, flu, vaccine, Flu-M

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • LLC "Meditsinskie Tehnologii"
  • LLC "Strategicheskie Meditsinskie Sistemi"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Flu-M

Ultrix

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).
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)
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%
Increasing of geometric mean titer in > 2.0 times
The percentage with protective antibody titer ≥ 1:40

Full Information

First Posted
October 11, 2021
Last Updated
December 16, 2021
Sponsor
St. Petersburg Research Institute of Vaccines and Sera
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1. Study Identification

Unique Protocol Identification Number
NCT05089123
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
May 28, 2020 (Actual)
Study Completion Date
August 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Petersburg Research Institute of Vaccines and Sera

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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: 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);

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, flu, vaccine, Flu-M

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flu-M
Arm Type
Experimental
Arm Description
160 volunteers were vaccinated with the Flu-M inactivated split influenza vaccine with a preservative
Arm Title
Ultrix
Arm Type
Active Comparator
Arm Description
160 volunteers were vaccinated with the Ultrix (Inactivated split influenza vaccine)
Intervention Type
Biological
Intervention Name(s)
Flu-M [Inactivated split influenza vaccine]
Intervention Description
solution for intramuscular injection, 0.5 ml
Intervention Type
Biological
Intervention Name(s)
Inactivated Split Influenza Vaccine
Intervention Description
solution for intramuscular injection, 0.5 ml
Primary Outcome Measure Information:
Title
Immunogenicity assessment
Description
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)
Time Frame
21 days
Secondary Outcome Measure Information:
Title
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).
Time Frame
21 days
Title
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)
Time Frame
21 days
Title
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%
Time Frame
21 days
Title
Increasing of geometric mean titer in > 2.0 times
Time Frame
21 days
Title
The percentage with protective antibody titer ≥ 1:40
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
LLC "Meditsinskie Tehnologii"
City
Saint Petersburg
Country
Russian Federation
Facility Name
LLC "Strategicheskie Meditsinskie Sistemi"
City
Saint Petersburg
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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