InfluenzaPhase 2/3NCT05869201
Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro, Tetravalent Inactivated Split Influenza Vaccine
A Phase 2/3 study testing Influenza vaccine [inactivated] in people with Influenza and Influenza, Human, run by St. Petersburg Research Institute of Vaccines and Sera at 5 sites in Russia.
Trial summary
The goal of this clinical trial is to assess tolerability, safety and immunogenicity of the Flu-M Quadro vaccine as compared to the Ultrix® Quadri vaccine in volunteers aged between 18 and 60. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza, Human, Influenza Viral Infections
- What is being tested?
- Influenza vaccine [inactivated]
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 5 sitesRussia
- Study dates
- 6 Oct 2020to 8 Dec 2020
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers (men and women) aged 18-60;
- Written informed consent of the volunteers to participate in the clinical trial;
- Volunteers able to fulfill requirements of the protocol (i.e., fill out the patient's diary, come to follow-up visits);
- For fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception (usage of contraceptives one month before vaccination and at least two months after vaccination). All females with childbearing potential must have a negative pregnancy test result during the screening period. In the course of the trial women should use barrier contraceptives with a reliability exceeding 90 %, or be sterile, or be in a postmenopausal state. Barrier contraceptives with a reliability exceeding 90 % of common use include cervical caps with spermicide, diaphragms with spermicide, condoms, intra-uterine spirals;
- For the men, are able to conceive - consent to use adequate contraception methods. In the course of the trial and during at least two months after vaccination, men and their sexual partners should use barrier contraceptives with a reliability exceeding 90 %, or be sterile. Barrier contraceptives with a reliability exceeding 90 % of common use include cervical caps with spermicide, diaphragms with spermicide, condoms, intra-uterine spirals;
Who cannot join
- History of influenza or ARVI or previous influenza vaccination during 9 moths before the trial;
- A serious post-vaccination 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 after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination);
- Allergic reactions to vaccine components or any previous vaccination;
- History of allergic reaction to chicken protein;
- History of Guillain-Barré syndrome (acute polyneuropathy);
- Previous vaccination with rabies vaccines less than 2 months before immunization or scheduled vaccination with rabies vaccines within 1 month after immunization with the trial vaccines;
Show all 23Show fewer
- Use of any vaccines within 1 month before the vaccination, excluding vaccines according to the National Calendar of Preventive Vaccination, including for epidemic reasons;
- History of leukemia, tuberculosis, cancer, autoimmune diseases;
- Positive blood test results for HIV, syphilis, hepatitis B/C.
- Volunteers who received immunoglobulin or blood products or had a blood transfusion during the last three months before the trial;
- History of long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for six months before the trial;
- History of any confirmed or suspected immunosuppressive or immunodeficiency condition;
- History of chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, the gastrointestinal tract, liver, kidneys, hematopoietic or immune systems, mental disease in the acute stage or in the decompensation stage (recovery less than 4 weeks before vaccination);
- History of progressive neurological pathology, convulsive syndrome; Diabetes mellitus, thyrotoxicosis or other diseases of the endocrine system;
- History of eczema;
- Treatment with glucocorticosteroids, including in small doses, as well as local use of drugs containing steroids (> 10 mg of prednisolone or its equivalent for more than 14 days during the last three months);
- According to the medical history, the volunteer was/is a patient of a tuberculosis dispensary and/or narcological dispensary and/or neuropsychiatric dispensary and/or other;
- History of acute infectious diseases (recovery less than 4 weeks before vaccination);
- Consumption of more than 10 units of alcoholic drinks per week or history of alcohol addiction, drug addiction or abuse of pharmaceutical products;
- Smoking of more than 10 cigarettes per day;
- Participation in another clinical trial during the last 3 months;
- Pregnancy or lactation;
- Serious concurrent illnesses or pathological conditions not listed above which, in the opinion of the investigator, could complicate the assessment of the results of the trial including pathological deviations from age norms and laboratory norms of blood and urine parameters, which are clinically significant in the opinion of the investigator
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Russia5 sites
Federally Funded Healthcare Institution Primary Healthcare Unit No. 163,of Federal Medical and Biologic Agency (FFHI PHU No. 163, FMBA of Russia)
Kol'tsovo, Novosibirsk Oblast
Bessalar Clinic. Clinical Trial Center Limited Liability Company (Bessalar Clinic. Clinical Trial Center LLC)
Moscow
Federation (FSBEI of Higher Education "E. A. Wagner PSMU" of the of the Ministry of Health of the Russian Federation)
Perm
Baltic Medicine Limited Liability Company (Baltic Medicine LLC)
Saint Petersburg
Eco-Safety Scientific Research and Development Center Limited Liability Company (Eco-Safety Scientific Research and Development Center LLC)
Saint Petersburg
About this study
Official title: Double-blind Comparative Randomized Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro Tetravalent Inactivated Split Influenza Vaccine, Solution for Intramuscular Injection, FSUE SPbSRIVS FMBA of Russia, in Volunteers Aged 18-60 Years
The goal of this clinical trial is to assess tolerability, safety and immunogenicity of the Flu-M Quadro vaccine as compared to the Ultrix® Quadri vaccine in volunteers aged between 18 and 60.
Participants were given Flu-M Quadro [inactivated split influenza vaccine] with preservative or Flu-M Quadro [inactivated split influenza vaccine] without preservative or Ultrix® Quadri vaccine.The volunteers of each group were vaccinated with a single dose vaccine.
Read more
Researchers assessed the tolerability, safety and immunogenicity of the Flu-M Quadro quadrivalent inactivated split influenza vaccine.
Researchers performed a comparative assessment of the tolerability, safety, and immunogenicity of the Flu-M Quadro quadrivalent inactivated split influenza vaccine and the Ultrix® Quadri vaccine.
- Conditions
- Influenza, Influenza, Human, Influenza Viral Infections, Vaccine Reaction, Vaccination; Infection
- Being tested
- Influenza vaccine [inactivated]
- Keywords
- Influenza, Flu, Vaccine, Vaccination, SPbSRIVS, Flu-M Tetra, Flu-M Quadro, Quadrivalent, Inactivated, Split
- 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.
Influenza vaccine [inactivated]Biological
Also called Flu-M Quadro (with a preservative)
Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine
Influenza vaccine [inactivated]Biological
Also called Flu-M Quadro (without preservative)
Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine
Influenza vaccine [inactivated]Biological
Also called Ultrix® Quadri
Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine
| Study group | Role | What they receive |
|---|---|---|
| Flu-M Quadro with preservative | Experimental | 150 volunteers were vaccinated with the Flu-M Quadro Inactivated Split Influenza Vaccine with a preservative Receives: Biological: Influenza vaccine [inactivated] |
| Flu-M Quadro without preservative | Experimental | 150 volunteers were vaccinated with the Flu-M Quadro Inactivated Split Influenza Vaccine without a preservative Receives: Biological: Influenza vaccine [inactivated] |
| Ultrix® Quadri | Active comparator | 150 volunteers were vaccinated with Ultrix® Quadri Vaccine Receives: Biological: Influenza vaccine [inactivated] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate for each virus strain (A (H1N1), A (H3N2) and B (Yamagata line and Victoria line)) The percentage of subjects who have a prevaccination titer of influenza haemagglutinin antibody titer (HA titer) ≤ 1:10 and a postvaccination HA titer
Measured: Screening (Days 0+5), Day 28
Secondary outcomes (21)
Change from Baseline Geometric mean titer (GMT) ratio of antibodies for each virus strain (A (H1N1), A (H3N2) and B (Yamagata line and Victoria line))
Geometric mean titer (GMT) of antibodies in the blood serums of vaccinated participants in haemagglutination inhibition assay
Measured: Screening (Days 0+5), Day 28
Seroconversion factor for each virus strain (A (H1N1), A (H3N2) and B (Yamagata line and Victoria line)) Seroconversion factor is an increase in the geometric mean titers of antibodies at Day 28 vs. the baseline level, expressed in the fold rise
Measured: Screening (Days 0+5), Day 28
Seroprotection rate for each virus strain (A (H1N1), A (H3N2) and B (Yamagata line and Victoria line)) Seroprotection rate is the percentage of subjects with a generated protective HA titer (at least 1:40) vs. the baseline level
Measured: Screening (Days 0+5), Day 28
Incidence of influenza and ARVI
Incidence, severity, and duration of influenza and ARVI during 6 months after vaccination detected outside of the Protocol.
Measured: During 6 months after vaccination
Incidence of immediate adverse events (allergic reactions)
Measured: 2 hours after vaccination
Incidence of local adverse events
Measured: 7 days after vaccination
Incidence of systemic adverse events
Measured: 7 days after vaccination
Incidence of other adverse reactions
Measured: Days 8 to 28 after vaccination
Incidence of severe adverse events
Measured: Days 1 to 28 after vaccination
Incidence of withdrawal of a volunteer from the trial due to development of an AE/SAE associated with the use of the trial products
Measured: Days 1-7, 14
Number of participants with abnormal physical examination findings
Physical examination of volunteers included an interview, discovery of complaints and symptoms, when required, palpation, auscultation, percussion. During the interview, all complaints and symptoms that had developed since the last visit were identified and assessed. An examination and (when applicable) palpation, auscultation, percussion were performed for the following organs and systems: skin, mucosa, eyes, oral cavity and pharynx, lungs/chest, heart/cardiovascular system, abdominal organs, nervous system, lymph nodes, musculoskeletal system, thyroid gland. The palpation analysis of lymph nodes (submandibular, cervical, ulnar) included an assessment of their size, consistency, pain, mobility, adhesion between themselves and with surrounding tissues and skin
Measured: Screening (Days 0+5), Days 1-7, 14, 28
Number of participants with abnormal changes in vital signs - Blood pressure (BP)
BP measurements include the systolic and diastolic blood pressure
Measured: Screening (Days 0+5), Days 1-7, 14, 28
Number of participants with abnormal changes in vital signs - Heart rate (HR)
HR is measured using a phonendoscope at the apex of the heart during 1 minute
Measured: Screening (Days 0+5), Days 1-7, 14, 28
Number of participants with abnormal changes in vital signs - Respiratory rate (RR)
Measured: Screening (Days 0+5), Days 1-7, 14, 28
Number of participants with abnormal changes in vital signs - Body temperature
Body temperature was measured using mercury or digital thermometer, in the armpit for at least 5 minutes
Measured: Screening (Days 0+5), Day 1 - before vaccination, 20 minutes and 2, 5-8 hours after vaccination; Days 2-7, 14, 28
Number of participants with clinically significant abnormalities - Complete blood count (CBC)
Red blood cells, Hemoglobin, ESR, Differential Leukocyte Count (segmented and rod neutrophils, lymphocytes, monocytes, eosinophils, basophils), Platelets
Measured: Screening (Days 0+5), Days 3, 14, 28
Number of participants with clinically significant abnormalities - Biochemical blood test (BBT)
ALT, AST, Alkaline phosphatase, Total Bilirubin, Total Protein, Urea, Glucose, C-reactive protein, Creatinine, Cholesterol
Measured: Screening (Days 0+5), Days 3, 14, 28
Number of participants with clinically significant abnormalities - Urinalysis
pH, Relative Density/Specific Gravity, Protein, Glucose, Red Blood Cells, White Blood Cells
Measured: Screening (Days 0+5), Days 3, 14, 28
Number of participants with abnormal changes of total IgE
Measured: Screening (Days 0+5), Days 3, 14, 28
Number of participants with abnormal neurological examinations
Measured: Screening (Days 0+5), Days 1, 3 (When the interval between the screening visit and visit 1 is more than 3 days), 14, 28
Number of participants with abnormal electrocardiography results
Standard 12-lead ECG
Measured: Screening (Days 0+5), Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start6 Oct 2020
- Primary completion8 Dec 2020
- Study completion8 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Petersburg Research Institute of Vaccines and Sera
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ellina Ruzanova, Study director, St. Petersburg Research Institute of Vaccines and Sera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869201
- Sponsor's protocol ID
- FMK-II/III-02/20
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Comparative Randomized Tolerability, Safety and Immunogenicity Trial of the Flu-M Quadro Tetravalent Inactivated Split Influenza Vaccine, Solution for Intramuscular Injection, FSUE SPbSRIVS FMBA of Russia, in Volunteers Aged 18-60 Years
- ClinicalTrials.gov ID
- NCT05869201
- Acronym / sponsor ID
- FMK-II/III-02/20
- Conditions
- Influenza, Influenza, Human, Influenza Viral Infections, Vaccine Reaction, Vaccination; Infection
- Keywords
- Influenza, Flu, Vaccine, Vaccination, SPbSRIVS, Flu-M Tetra, Flu-M Quadro, Quadrivalent
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- St. Petersburg Research Institute of Vaccines and SeraOther government
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess tolerability, safety and immunogenicity of the Flu-M Quadro vaccine as compared to the Ultrix® Quadri vaccine in volunteers aged between 18 and 60.
Participants were given Flu-M Quadro [inactivated split influenza vaccine] with preservative or Flu-M Quadro [inactivated split influenza vaccine] without preservative or Ultrix® Quadri vaccine.The volunteers of each group were vaccinated with a single dose vaccine.
Researchers assessed the tolerability, safety and immunogenicity of the Flu-M Quadro quadrivalent inactivated split influenza vaccine.
Researchers performed a comparative assessment of the tolerability, safety, and immunogenicity of the Flu-M Quadro quadrivalent inactivated split influenza vaccine and the Ultrix® Quadri vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flu-M Quadro with preservative | Experimental | Biological: Influenza vaccine [inactivated]150 volunteers were vaccinated with the Flu-M Quadro Inactivated Split Influenza Vaccine with a preservative |
| Flu-M Quadro without preservative | Experimental | Biological: Influenza vaccine [inactivated]150 volunteers were vaccinated with the Flu-M Quadro Inactivated Split Influenza Vaccine without a preservative |
| Ultrix® Quadri | Active comparator | Biological: Influenza vaccine [inactivated]150 volunteers were vaccinated with Ultrix® Quadri Vaccine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers (men and women) aged 18-60;
- Written informed consent of the volunteers to participate in the clinical trial;
- Volunteers able to fulfill requirements of the protocol (i.e., fill out the patient's diary, come to follow-up visits);
- For fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception (usage of contraceptives one month before vaccination and at least two months after vaccination). All females with childbearing potential must have a negative pregnancy test result during the screening period. In the course of the trial women should use barrier contraceptives with a reliability exceeding 90 %, or be sterile, or be in a postmenopausal state. Barrier contraceptives with a reliability exceeding 90 % of common use include cervical caps with spermicide, diaphragms with spermicide, condoms, intra-uterine spirals;
- For the men, are able to conceive - consent to use adequate contraception methods. In the course of the trial and during at least two months after vaccination, men and their sexual partners should use barrier contraceptives with a reliability exceeding 90 %, or be sterile. Barrier contraceptives with a reliability exceeding 90 % of common use include cervical caps with spermicide, diaphragms with spermicide, condoms, intra-uterine spirals;
Key exclusion criteria (23 listed)
- History of influenza or ARVI or previous influenza vaccination during 9 moths before the trial;
- A serious post-vaccination 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 after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination);
- Allergic reactions to vaccine components or any previous vaccination;
- History of allergic reaction to chicken protein;
- History of Guillain-Barré syndrome (acute polyneuropathy);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccine [inactivated]Also: Flu-M Quadro (with a preservative)Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine | Biological | Flu-M Quadro with preservative |
| Influenza vaccine [inactivated]Also: Flu-M Quadro (without preservative)Solution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine | Biological | Flu-M Quadro without preservative |
| Influenza vaccine [inactivated]Also: Ultrix® QuadriSolution for intramuscular injection, 0.5 ml (1 dose) Vaccination with a single dose vaccine | Biological | Ultrix® Quadri |
Primary outcome
Seroconversion rate for each virus strain (A (H1N1), A (H3N2) and B (Yamagata line and Victoria line)) The percentage of subjects who have a prevaccination titer of influenza haemagglutinin antibody titer (HA titer) ≤ 1:10 and a postvaccination HA titer
Time frame: Screening (Days 0+5), Day 28
21 secondary outcomes
Change from Baseline Geometric mean titer (GMT) ratio of antibodies for each virus strain (A (H1N1), A (H3N2) and B (Yamagata line and Victoria line))
Time frame: Screening (Days 0+5), Day 28
Seroconversion factor for each virus strain (A (H1N1), A (H3N2) and B (Yamagata line and Victoria line)) 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: Screening (Days 0+5), Day 28
Seroprotection rate for each virus strain (A (H1N1), A (H3N2) and B (Yamagata line and Victoria line)) Seroprotection rate is the percentage of subjects with a generated protective HA titer (at least 1:40) vs. the baseline level
Time frame: Screening (Days 0+5), Day 28
Incidence of influenza and ARVI
Time frame: During 6 months after vaccination
Incidence of immediate adverse events (allergic reactions)
Time frame: 2 hours after vaccination
Incidence of local adverse events
Time frame: 7 days after vaccination
Incidence of systemic adverse events
Time frame: 7 days after vaccination
Incidence of other adverse reactions
Time frame: Days 8 to 28 after vaccination
Incidence of severe adverse events
Time frame: Days 1 to 28 after vaccination
Incidence of withdrawal of a volunteer from the trial due to development of an AE/SAE associated with the use of the trial products
Time frame: Days 1-7, 14
Number of participants with abnormal physical examination findings
Time frame: Screening (Days 0+5), Days 1-7, 14, 28
Number of participants with abnormal changes in vital signs - Blood pressure (BP)
Time frame: Screening (Days 0+5), Days 1-7, 14, 28
Number of participants with abnormal changes in vital signs - Heart rate (HR)
Time frame: Screening (Days 0+5), Days 1-7, 14, 28
Number of participants with abnormal changes in vital signs - Respiratory rate (RR)
Time frame: Screening (Days 0+5), Days 1-7, 14, 28
Number of participants with abnormal changes in vital signs - Body temperature
Time frame: Screening (Days 0+5), Day 1 - before vaccination, 20 minutes and 2, 5-8 hours after vaccination; Days 2-7, 14, 28
Number of participants with clinically significant abnormalities - Complete blood count (CBC)
Time frame: Screening (Days 0+5), Days 3, 14, 28
Number of participants with clinically significant abnormalities - Biochemical blood test (BBT)
Time frame: Screening (Days 0+5), Days 3, 14, 28
Number of participants with clinically significant abnormalities - Urinalysis
Time frame: Screening (Days 0+5), Days 3, 14, 28
Number of participants with abnormal changes of total IgE
Time frame: Screening (Days 0+5), Days 3, 14, 28
Number of participants with abnormal neurological examinations
Time frame: Screening (Days 0+5), Days 1, 3 (When the interval between the screening visit and visit 1 is more than 3 days), 14, 28
Number of participants with abnormal electrocardiography results
Time frame: Screening (Days 0+5), Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellina Ruzanova study director
St. Petersburg Research Institute of Vaccines and Sera
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Influenza vaccine [inactivated] in people with Influenza and Influenza, Human, 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 5 inclusion and 23 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 22 May 2023. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Seroconversion rate for each virus strain (A (H1N1), A (H3N2) and B (Yamagata line and Victoria line)) The percentage of subjects who have a prevaccination titer of influenza haemagglutinin antibody titer (HA titer) ≤ 1:10 and a postvaccination HA titer (time frame: Screening (Days 0+5), Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2023.