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
- Conditions
- Influenza
- Registration Number
- NCT05089123
- 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:
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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
- 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)).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Immunogenicity assessment 21 days 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
Name Time Method Increasing of geometric mean titer in > 2.0 times 21 days The percentage with protective antibody titer ≥ 1:40 21 days 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
Trial Locations
- Locations (2)
LLC "Meditsinskie Tehnologii"
🇷🇺Saint Petersburg, Russian Federation
LLC "Strategicheskie Meditsinskie Sistemi"
🇷🇺Saint Petersburg, Russian Federation
LLC "Meditsinskie Tehnologii"🇷🇺Saint Petersburg, Russian Federation