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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05089123
• Other study ID #: FM-2019-02
• Status: Completed
• Phase: Phase 3
• Start date: March 3, 2020
• Est. completion date: August 24, 2020

Study information

• Verified date: October 2021
• Source: St. Petersburg Research Institute of Vaccines and Sera
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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:

1. Screening period (up to 7 days):

• Visit 0 (day -7...-1).

2. Vaccination period (up to 1 day):

• Visit 1 (day 1, randomization, blood collection for serological examination, vaccination).

3. 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);

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: August 24, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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 38.5??, 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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Flu-M [Inactivated split influenza vaccine]
solution for intramuscular injection, 0.5 ml
• Inactivated Split Influenza Vaccine
solution for intramuscular injection, 0.5 ml

Locations

Country	Name	City	State
Russian Federation	LLC "Meditsinskie Tehnologii"	Saint Petersburg
Russian Federation	LLC "Strategicheskie Meditsinskie Sistemi"	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg Research Institute of Vaccines and Sera

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Increasing of geometric mean titer in > 2.0 times		21 days
Secondary	The percentage with protective antibody titer = 1:40		21 days