A Phase 2/3 interventional study of Flu-M Tetra [Inactivated split influenza vaccine] w/p and Flu-M Tetra [Inactivated split influenza vaccine] w/o/p in Influenza, sponsored by St. Petersburg Research Institute of Vaccines and Sera. Completed at 11 sites in Russian Federation. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by St. Petersburg Research Institute of Vaccines and Sera · Phase 2/3, Interventional, and Prevention
Comparative assessment of the tolerability, safety, and immunogenicity of the FLU-M® Tetra quadrivalent inactivated split influenza vaccine and the Ultrix® vaccine in volunteers aged 60 years and above.
Evaluation of the tolerability, safety and immunogenicity of the inactivated split influenza vaccine FLU-M® Tetra compared to Ultrix® vaccine in volunteers aged 60 years and above.
Volunteers were screened and randomized in three groups: the Flu-M Tetra w/p (with preservative) group, the Flu-M Tetra w/o/p (without preservative) group and the Ultrix® group. All subjects were followed up for 28 days post randomization and vaccination.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 633 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →St. Petersburg Research Institute of Vaccines and Sera is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Flu-M Tetra vaccine (with preservative) intramuscularly
Biological: Flu-M Tetra [Inactivated split influenza vaccine] w/p
211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Flu-M Tetra vaccine (without preservative) intramuscularly.
Biological: Flu-M Tetra [Inactivated split influenza vaccine] w/o/p
211 volunteers aged 60 y.o. and older received a single intramuscular dose of the Ultrix vaccine.
Biological: Ultrix [Inactivated split influenza vaccine]
solution for intramuscular injection, 0.5 ml
solution for intramuscular injection, 0.5 ml
solution for intramuscular injection, 0.5 ml
Geometric mean titer (GMT) ratio of antibodies after vaccination
Geometric mean titer (GMT) of antibodies in the blood serums of vaccinated people in haemagglutination inhibition assay.
Time frame: days 0, 28
Change from baseline seroconversion rate at 28 days
Seroconversion rate refers to the percentage of subjects who have a prevaccination titer of influenza haemagglutinin antibody titer (HA titer) ≤ 1:10 and a post-vaccination HA titer ≥ 1:40 or a prevaccination HA titer \> 1:10 and at least a 4-fold increase in post-vaccination HA titer vs. the baseline.
Time frame: days 0, 28
Seroconversion factor
Seroconversion factor is an increase in the geometric mean titers of antibodies at Day 28 vs. the baseline level, expressed in the fold rise.
Time frame: days 0, 28
Seroprotection rate
Seroprotection rate refers to the percentage of subjects with a generated protective HA titer (at least 1:40) vs. the baseline level.
Time frame: days 0, 28
Frequency of development of AEs associated with the vaccination
An adverse event (AE) is any adverse medical occurrence in a trial subject who has received a pharmaceutical product or medicine that does not necessarily have a causal relationship with the medicine. AE include: new disease, complication of signs or symptoms of the condition being treated or a concomitant disease, effect of the trial drug or the reference drug, effect associated with a trial procedure, any combination of one or more of these factors.
Time frame: days 0-28
Frequency of development of SAEs associated with the vaccination
An adverse event is considered serious if it is fatal, threatens the life, requires hospitalization or extension of hospitalization, results in permanent or significant disability, is a congenital abnormality or defect (not applicable to this trial), is an important medical event.
Time frame: days 0-28
Number of participants with abnormal physical examination findings
Physical examination of volunteers includes an interview, discovery of complaints and symptoms, when required, palpation, auscultation, percussion for the following organs and systems: skin, mucosa, eyes, oral cavity and pharynx, lungs/chest, cardiovascular system, abdominal organs, nervous system, lymph nodes, musculoskeletal system, endocrine system.
Time frame: days 0,1,3,7,28
Results of assessment of blood pressure (BP)
BP measurements include the systolic and diastolic blood pressure.
Time frame: days 0,1,3,7,28
Results of assessment of heart rate (HR)
HR is measured during auscultation of the heart in parallel with determining the pulse rate on the radial artery (or on the carotid artery in case of weak pulsation in the radial artery) for a minute while sitting.
Time frame: days 0,1,3,7,28
Results of E immunoglobulin tests
Determination of total IgE.
Time frame: days 0,3,28
Results of assessment of respiratory rate (RR)
RR is measured for a minute at rest in the sitting position, by registering the breathing movements of the chest or abdominal wall, without attracting the patient's attention.
Time frame: days 0,1,3,7,28
Results of assessment of body temperature
Body temperature is measured with a mercury or digital thermometer in the armpit for at least 5 minutes or with a non-contact infrared digital thermometer.
Time frame: days 0,1,3,7,28
Number of participants with abnormal neurological examinations
Assessement of neurological status, cranial nerve function, motor sphere, reflex sphere, sensitive sphere, coordination sphere, pelvic functions, higher mental functions.
Time frame: days 0,1,3,7,28
Number of participants with abnormal ECG findings
ECG QT Interval, QTc Interval, PQ Interval, QRS complex.
Time frame: days 0,3
Number of participants with abnormal complete blood counts results
Hemoglobin, hematocrit, erythrocytes, leukocytes, platelets, leukocyte count, ESR.
Time frame: days 0,3
Number of participants with abnormal biochemical blood tests results
Total protein, creatinine, urea, glucose, total bilirubin, total cholesterol, AST, ALT, ALP.
Time frame: days 0,3
Number of participants with abnormal urinalysis results
pH, specific gravity, protein, glucose, red blood cells, white blood cells
Time frame: days 0,3
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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St. Petersburg Research Institute of Vaccines and Sera