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Influenza, HumanPhase 3NCT05457894

Trial of Tolerability, Reactogenicity, Safety and Immunogenicity of Flu-M [Inactivated Split Influenza Vaccine] in Pregnant Women

A Phase 3 study testing Flu-M, Inactivated split influenza vaccine and Ultrix®, Inactivated Split Influenza Vaccine in people with Influenza, Human and Vaccination; Infection, run by St. Petersburg Research Institute of Vaccines and Sera at 5 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Comparative study of tolerability, reactogenicity, safety and immunogenicity Flu-M [Inactivated Split Influenza Vaccine] vs. the Ultrix® vaccine for the prevention of influenza in pregnant women in the 2nd-3rd trimesters of pregnancy Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Influenza, Human, Vaccination; Infection, Vaccines
What is being tested?
Flu-M, Inactivated split influenza vaccine and Ultrix®, Inactivated Split Influenza Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
207 participants
Where
5 sitesRussia
Study dates
23 Jan 2020to 26 Jul 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Presence of signed Informed Consent of the female patient to participate in the trial
  • Healthy women aged 18 to 35 years in their 2nd and 3rd trimesters of pregnancy with gestational age of no more than 32 weeks
  • Singleton pregnancy progressing normally
  • No contraindications for vaccination
  • Pregnant women that are able to fulfill the requirements of the protocol (i.e., fill out the Self-Observation Diary, come to follow-up visits)
  • The investigator is given the opportunity to collect data about somatic, infectious, and allergic diseases within at least 3 months from vaccination (one or more calls from the clinical investigator or visits per month (as needed))

Who cannot join

  • Body temperature above 37°С
  • History of influenza or previous influenza vaccination during 6 months before the screening
  • History of allergic reactions to chicken protein
  • Allergic reactions to vaccine components or any previous vaccination
  • Gestational toxicosis
  • Any disorders of pregnancy
Show all 27Show fewer
  • Thyroid disorders
  • Bronchial asthma
  • Clotting disorders
  • 1, 2 type diabetes mellitus
  • High risk of fetal chromosomal abnormalities (individual risk of at least 1/100) in the 1st trimester of pregnancy and/or the detection of fetal congenital anomalies / developmental defects in the 1st, 2nd, and 3rd trimesters of pregnancy
  • Strong reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) or complications (collapse or shock-like condition) that developed within 48 hours from prior vaccination; convulsions accompanied or not accompanied by a fever due to any prior vaccination
  • Acute infectious or non-infectious diseases less than 4 weeks before the screening, exacerbation of chronic diseases (the vaccination can be carried out after recovery or in the period of remission)
  • Immunomodulatory therapy, including immune-enhancing, immunosuppressive therapy (corticosteroids, cytotoxic and radioactive drugs) in the 6 months preceding the trial
  • Any other contraindications against vaccination according to the investigator.
  • Leukemia, cancer or a positive reaction to HIV infection, hepatitis B and C, syphilis in the medical history
  • Volunteers who received immunoglobulin or blood products within the last three months before the trial
  • History of Guillain-Barré syndrome (acute polyneuropathy)
  • Autoimmune diseases
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition
  • Respiratory, cardiovascular failure, impaired liver or kidney function.
  • Severe birth defects or serious chronic diseases, including any clinically significant chronic diseases of lungs, kidneys, cardiovascular, nervous system, psychiatric diseases or metabolic disorders, confirmed by medical history or objective examination
  • Vaccination with any vaccine less than 30 days before the screening or scheduled vaccination with any vaccine within 30 days from vaccination with the trial vaccines
  • The woman is/was a patient of a tuberculosis dispensary and/or narcological dispensary and/or neuropsychiatric dispensary
  • Chronic alcohol abuse and/or use of drugs in the past history
  • Smoking
  • Participation in another clinical trial during the last 3 months

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Russia5 sites

  • Federal State Budgetary Educational Institution of Higher Education "Altai State Medical University" of the Ministry of Health of the Russian Federation

    Barnaul, Altai Territory

  • "Curator" Limited Liability Company

    Saint Petersburg

  • KOROLEV MEDICINE Limited Liability Company

    Saint Petersburg

  • Federal State Budgetary Institution "Siberian Federal Scientific and Clinical Center of Federal Medical and Biologic Agency"

    Seversk, Tomsk Oblast

  • Municipal Budgetary Institution "Central City Hospital No.7"

    Yekaterinburg

Other trials in Russia

About this study

Official title: Randomized, Double-blind, Comparative, Controlled Trial of Tolerability, Reactogenicity, Safety and Immunogenicity of Flu-M [Inactivated Split Influenza Vaccine] in Pregnant Women During the 2nd - 3rd Trimester

Comparative study of tolerability, reactogenicity, safety and immunogenicity Flu-M [Inactivated Split Influenza Vaccine] vs. the Ultrix® vaccine for the prevention of influenza in pregnant women in the 2nd-3rd trimesters of pregnancy

Read the detailed description

This is a randomized, double-blind, comparative, controlled trial. A design with a control group treated with Ultrix®, inactivated influenza vaccine, was chosen to obtain objective findings.Trial population: healthy women aged 18 to 35 years during the 2nd and 3rd trimesters of pregnancy. Subjects were randomized into 4 groups in a ratio of 1:1:1:1, 50 subjects per group.

Being tested
Flu-M, Inactivated split influenza vaccine, Ultrix®, Inactivated Split Influenza Vaccine
Keywords
Influenza, Flu, Vaccine, FLU-M, SPbSRIVS, Ultrix
Medical subject headings
Influenza, Human, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flu-M, Inactivated split influenza vaccineBiological

    solution for intramuscular injection, 0.5 ml

  • Ultrix®, Inactivated Split Influenza VaccineBiological

    solution for intramuscular injection, 0.5 ml

Study groups in NCT05457894
Study groupRoleWhat they receive
Flu-M, II trimester of pregnancyExperimentalSubjects during their II trimester of pregnancy (gestational age: 14-26 weeks), immunized once with the Flu-M vaccine.
Receives: Biological: Flu-M, Inactivated split influenza vaccine
Ultrix®, II trimester of pregnancyActive comparatorSubjects during their II trimester of pregnancy (gestational age: 14-26 weeks), immunized once with Ultrix®.
Receives: Biological: Ultrix®, Inactivated Split Influenza Vaccine
Flu-M, III trimester of pregnancyExperimentalSubjects during their III trimester of pregnancy (gestational age: 27-32 weeks), will be immunized once with the Flu-M vaccine.
Receives: Biological: Flu-M, Inactivated split influenza vaccine
Ultrix®, III trimester of pregnancyActive comparatorSubjects during their III trimester of pregnancy (gestational age: 27-32 weeks), immunized once with Ultrix®.
Receives: Biological: Ultrix®, Inactivated Split Influenza Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Seroprotection rate at day 21 after vaccination

    The percentage of vaccinees who have an antibody titer of more than 1:40 by Day 21 after vaccination.

    Antibodies to influenza B, А (H1N1), А (H3N2) viruses Seroprotection rate ≥ 70%.

    Measured: Days 0 (screening), 21

  2. Change from Baseline Seroconversion rate at day 21 after vaccination

    The relative number of vaccinees, whose titer of hemagglutinin inhibiting antibodies has increased by more than 4 times vs. baseline among all immunoprotective persons.

    Antibodies to influenza B, А (H1N1), А (H3N2) viruses Seroconversion rate ≥ 40%

    Measured: Days 0 (screening), 21

  3. Change from Baseline Seroconversion factor at day 21 after vaccination

    An increase in the geometric mean titers of hemagglutinin inhibiting antibodies on Day 21 vs. baseline, expressed in multiplicity of increase.

    Antibodies to influenza B, А (H1N1), А (H3N2) viruses Seroconversion factor ≥ 2.5

    Measured: Days 0 (screening), 21

Secondary outcomes (16)

  1. Incidence of AEs and SAEs associated with vaccination

    The degree of intensity or severity of AE was evaluated on a 4-point scale:

    0 - none (no symptoms)

    1. - mild (mild symptoms)
    2. - moderate (symptoms that disrupt normal daily activities to a certain extent)
    3. - severe (symptoms that disrupt normal daily activities)

    Measured: Day 1 (30 minutes, 3 and 5 hours after vaccination), days 2-21

  2. Number of participants with abnormal changes in physical examination data

    Physical examination includes examination of the general appearance, condition of the skin and mucous membranes, neck (including the thyroid gland), eyes, ears, nasopharynx, lungs, heart, abdomen, liver, back, lymph nodes Table 6

    Measured: Days 0-7, day 21

  3. Number of participants with abnormal changes in vital signs - Blood pressure (BP)

    BP is measured in a sitting position after 10 minutes of rest

    Measured: Days 0-7, day 21

  4. Number of participants with abnormal changes in vital signs - Heart rate (HR)

    HR is measured in a sitting position after 10 minutes of rest

    Measured: Days 0-7, day 21

  5. Number of participants with abnormal changes in vital signs - Respiratory rate (RR)

    RR is measured in a sitting position after 10 minutes of rest

    Measured: Days 0-7, day 21

  6. Number of participants with abnormal changes in vital signs - Body temperature

    Body temperature is measured in the armpit

    Measured: Days 0, 1 (10 minutes before vaccination, 30 minutes and 2 and 5 hours after vaccination), days 2-7, day 21

  7. Incidence and severity of systemic post-injection reactions

    Measured: Day 1 (30 minutes, 3 and 5 hours after vaccination), days 2-21

  8. Incidence and severity of local post-injection reactions

    Measured: Day 1 (30 minutes, 3 and 5 hours after vaccination), days 2-21

  9. Number of participants with abnormal changes data obtained from examinations by immunologist-allergist

    Number of participants with clinically significant abnormalities

    Measured: Days 1-7, day 21

  10. Number of participants with abnormal changes of neurological examination data

    Number of participants with clinically significant abnormalities

    Measured: Days 0-7, day 21

  11. Number of participants with abnormal changes data obtained from examinations by obstetrician-gynecologist

    Examination: Respiratory organs, Blood circulation organs, Digestive organs, Organs of the urinary system, Mammary glands, Tone of the uterus, Fetal palpation results, Fetal auscultation results

    Measured: Days 0-7, day 21

  12. Number of participants with abnormal changes in the ultrasound data assessment of fetus and uterus

    Measured: Days 0 (screening), 21

  13. Number of participants with clinically significant abnormalities - Complete blood count (CBC)

    Red cells, Hemoglobin, ESR, White cells, Platelets, Relating to stab neutrophile, Segmented neutrophils, Lymphocytes, Eosinophils, Basophils, Monocytes

    Measured: Days 0 (screening), 3, 21

  14. Number of participants with clinically significant abnormalities - Biochemical blood test (BBT)

    Creatinine, Urea, Aspartate aminotransferase (AST), Alanine transaminase (ALT), Lactate dehydrogenase (LDH), Total protein, C-reactive protein, Alkaline phosphatase, Bilirubin, Glucose, Cholesterol, Prothrombin complex, Thymol test, β-lipoproteins

    Measured: Days 0 (screening), 3, 21

  15. Number of participants with clinically significant abnormalities - Urinalysis

    Density, Leukocytes, pH, color, urine glucose, urine erythrocytes, bacteria

    Measured: Days 0 (screening), 3, 21

  16. Number of participants with abnormal changes of total IgE

    Measured: Days 0 (screening), 3, 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2022
  2. Study start23 Jan 2020
  3. Primary completion11 Mar 2021
  4. Study completion26 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05457894
Sponsor's protocol ID
FM-2019-01
Status last verified
Jul 2022
First submitted
11 Jul 2022
Last updated
14 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Flu-M, Inactivated split influenza vaccine and Ultrix®, Inactivated Split Influenza Vaccine in people with Influenza, Human and Vaccination; Infection, run by St. Petersburg Research Institute of Vaccines and Sera at 5 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Seroprotection rate at day 21 after vaccination (time frame: Days 0 (screening), 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05457894.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.

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