InfluenzaPhase 2/3NCT03849560
Safety, Reactogenicity, Immunogenicity, Efficacy of Influenza Vaccines Grippol® Quadri and Grippol® Plus in Volunteers
A Phase 2/3 study testing Grippol® Quadri, Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) in people with Influenza, run by NPO Petrovax at 3 sites in Russia.
Trial summary
The aim of the study to assess the safety, reactogenicity, immunogenicity, and efficacy of quadrivalent inactivated subunit influenza vaccine Grippol® Quadri (NPO Petrovax Pharm, LLC, Russia) versus trivalent inactivated polymer-subunit vaccine Grippol® Plus (NPO Petrovax Pharm, LLC, Russia) in subjects from 18 to 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
- What is being tested?
- Grippol® Quadri, Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 3 sitesRussia
- Study dates
- Nov 2016to Aug 2017
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed and dated volunteer's informed consent for participation in the study.
- Men and women from 18 to 60 years old.
- Healthy volunteers without signs of acute or chronic disorders, without history of chronic respiratory, cardiovascular, nervous system disorders, hepatic or renal disorders.
- Previously not immunized, or previous influenza immunization occurring ≥ 12 months before this study.
- Subjects without history of influenza within ≥ 12 months before this study.
- Consent of volunteers (men and women) to use adequate methods of contraception (cervical caps with spermicide, diaphragms with spermicide, condoms with spermicide, intrauterine devices, oral contraceptives) or full abstinence for the whole period of the study.
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- Specific:
- Contraindications listed in the protocol and prescribing information for inactivated influenza vaccines:
- acute infections and non-communicable disorders, including the period of reconvalescence of at least one month from the time of clinical and laboratory evidence of recovery;
- hepatitis or meningococcal infection occurred less than 6 months after recovery;
- exacerbations of chronic disorder or decompensated disorders that may impact the study (organic central nervous system disorders, decompensated cardiovascular disorder, acute renal or hepatic failure);
- malignant neoplasms (including hematological disorders);
- primary immunodeficiency (laboratory-confirmed);
- HIV infection or HIV-associated disorders;
- systemic disorders of connective tissue;
- haemophilia (and other blood coagulation disorders);
- severe neurological disorders;
- Guillain-Barré syndrome (post infection demyelinating polyradiculoneuropathy of autoimmune nature with peripheral limb muscle palsy related to inflammation and destruction of myelin sheath of peripheral nerves; may acquire an ascending nature, involving muscles of face, pharynx, larynx);
- history of severe vaccine-associated reactions (body temperature exceeding 38.5 °С) or local reactions (hyperemia and/or oedema at the site of injection of over 5 cm in diameter);
- history of severe allergic disorders (angioedema, polymorphic exudative erythema, serum disease, etc.);
- hypersensitivity to chicken protein or vaccine components;
- blood and components transfusion within the last 6 months.
- Indications for immunomodulating therapy.
- Body temperature over 37.0 °С at screening or before injection.
- Potential evidence of a chronic infection (periodic episodes of fever within the last 6 months), or antiviral (and/or antibacterial) treatment indicated.
- History of disorders or conditions, which, according to investigator's judgment may impact the thermal regulation (chronic infections, neuroendocrine disorders [thyrotoxicosis, pheochromocytoma, etc.], climacteric syndrome, malignant hyperthermia, diseases of the central nervous system, malignant neoplasm, connective tissue disorders, systemic vasculitis, and information on excessive physical stress or work-rest regimen deviations [within the last 2 months: night shifts, significant change of time zones, overheating]).
- Use of antipyretics (including non-steroidal anti-inflammatory drugs and anilides) within 24 hours before randomization.
- Surgical interventions within less than 90 days before the screening visit.
- Systolic blood pressure of over 130 mm Hg or less than 100 mm Hg and/or diastolic blood pressure of over 90 mm Hg or less than 60 mm Hg.
- Any other disorder, which, in the opinion of the investigator, may prevent inclusion of the volunteer due to safety reasons or may impact the study results.
- General:
- Pregnant and nursing women.
- Lack of ability to visit daytime inpatient facility according to the study schedule, unavailability for adequate follow-up of the volunteer.
- Body mass index of less than 18.5 or over 30.0 kg/m2 based on the weight-height Quetelet's index.
- Participation in another clinical study of medicinal drugs within 3 months before the start of this study.
- Mental, physical, or other reasons which prevent adequate assessment of own behavior and prevent from meeting the study protocol conditions.
- History of narcotic and/or drug abuse, and/or inhalant addiction, current signs of alcoholic intoxication.
- Intake of at least 5 alcohol units per week or history of alcohol, drug, or medicinal product abuse. One alcohol unit corresponds to 360 ml of beer, 120 ml of wine, or 30 ml of a strong alcoholic beverage.
- Suspected lack of compliance with treatment or inability to undergo treatment and observe the limitations according to the study protocol.
- Volunteers acknowledged by the court to be disabled or under guardianship.
- Any other conditions that make the volunteer ineligible for the study according to a justified opinion of the study doctor or Sponsor.
Who cannot join
- Informed consent recall.
- Occurrence of a severe adverse events (AE) or serious adverse events.
- The volunteer is found to meet any of the non-inclusion criteria related to the safety of the volunteer participation in the study.
- If a female-volunteer becomes pregnant.
- The volunteer takes medicines not allowed in this study.
- The volunteer is lost to follow-up.
- In a situation, which, to the investigator's judgment, may adversely impact the volunteer if he/she continues participating in the study.
- For administrative reasons (study termination by the Sponsor or regulatory authorities) or in case of major protocol violations which may significantly impact the study results.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after academician I.P. Pavlova "of the Ministry of Health of the Russian Federation.
Saint Petersburg, Leningradskaya Oblast', 197022
Federal State Budgetary Institution "Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency"
Saint Petersburg, Leningradskaya Oblast', 197022
Smorodintsev Research Institute of Influenza
Saint Petersburg, Leningradskaya Oblast', 197376
About this study
Official title: A Multicenter, Double-Blind, Randomized, Parallel Group Study of Safety, Reactogenicity, Immunogenicity, and Efficacy of Quadrivalent Influenza Vaccine Grippol Quadri and Trivalent Influenza Vaccine Grippol Plus in Volunteers.
The aim of the study to assess the safety, reactogenicity, immunogenicity, and efficacy of quadrivalent inactivated subunit influenza vaccine Grippol® Quadri (NPO Petrovax Pharm, LLC, Russia) versus trivalent inactivated polymer-subunit vaccine Grippol® Plus (NPO Petrovax Pharm, LLC, Russia) in subjects from 18 to 60 years old.
Read the detailed description
The first Russian quadrivalent influenza vaccine was developed to improve the effectiveness of vaccination and the cost-effectiveness of preventive immunization.
Task of the study:
- Study and comparative assessment of the immunogenicity of the influenza quadrivalent inactivated subunit Grippol® Quadri vaccine in comparison with the trivalent inactivated polymer-subunit influenza vaccine Grippol® plus in volunteers aged 18-60 years.
- Evaluation of the safety and reactogenicity of the influenza quadrivalent inactivated subunit Grippol® Quadri vaccine in comparison with the trivalent inactivated polymer-subunit influenza vaccine Grippol® plus in volunteers aged 18-60 years.
- Study and comparative evaluation of the efficacy of the influenza quadrivalent inactivated subunit Grippol® Quadri vaccine in comparison with the trivalent inactivated polymer-subunit influenza vaccine Grippol® plus in volunteers aged 18-60 years.
- Conditions
- Influenza
- Being tested
- Grippol® Quadri, Grippol® Plus, trivalent (Yamagata lineage), Grippol® Plus, trivalent (Victoria lineage)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grippol® QuadriBiological
Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Quadri into the upper third of the outer surface of the shoulder (the deltoid muscle).
Grippol® Plus, trivalent (Yamagata lineage)Biological
Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Plus, trivalent (Yamagata lineage) into the upper third of the outer surface of the shoulder (the deltoid muscle).
Grippol® Plus, trivalent (Victoria lineage)Biological
Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Plus, trivalent (Victoria lineage) into the upper third of the outer surface of the shoulder (the deltoid muscle).
| Study group | Role | What they receive |
|---|---|---|
| Grippol® Quadri | Experimental | Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)
Active ingredients:
* type A (H1N1) influenza virus antigen 5 µg;
* type A (H3N2) influenza virus antigen 5 µg;
* type B (Yamagata lineage) influenza virus antigen 5 µg;
* type B (Victoria lineage) influenza virus antigen 5 µg;
* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg. Receives: Biological: Grippol® Quadri |
| Grippol® Plus, trivalent (Yamagata lineage) | Active comparator | Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.
Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)
Active ingredients:
* type A (H1N1) influenza virus antigen 5 µg;
* type A (H3N2) influenza virus antigen 5 µg;
* type B (Yamagata lineage) influenza virus antigen 5 µg;
* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg. Receives: Biological: Grippol® Plus, trivalent (Yamagata lineage) |
| Grippol® Plus, trivalent (Victoria lineage) | Active comparator | Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.
Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)
Active ingredients:
* type A (H1N1) influenza virus antigen 5 µg;
* type A (H3N2) influenza virus antigen 5 µg;
* type B (Victoria lineage) influenza virus antigen 5 µg;
* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg. Receives: Biological: Grippol® Plus, trivalent (Victoria lineage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects Achieving Seroconversion Increased More Than 4-fold Versus Baseline for Antigens: Influenza Virus Type А - H1N1, Influenza Virus Type А - H3N2, Influenza Virus Type В - Yamagata and Victoria Lineage
Percent of subjects achieving seroconversion (the number of volunteers with antibody titer [of at least 1:40] increased more than 4-fold versus baseline [assessed by HAIR]) for antigens: influenza virus type А - H1N1, influenza virus type А - H3N2, influenza virus type В - Yamagata and Victoria lineage, based on assessment at Visit 7.
Measured: Day 21 after immunization (Visit 7)
Secondary outcomes (9)
Geometric Mean of Serum Antibodies
To antigens: influenza virus type А - H1N1, influenza virus type А - H3N2, influenza virus type В - Yamagata and Victoria lineage.
Based on assessment at Visit 7.
Measured: Day 21 after immunization (Visit 7)
Seroprotection: Percent of Subjects Achieving Protective Antibody Titer (1:40 and More) to Antigens H1N1, H3N2, Yamagata and Victoria Lineage, Based on Assessment at Day 21 After Immunization (Visit 7).
Antibody titer is determined using the hemagglutination inhibition reaction (HAIR), the method recommended by the World Health Organization (WHO) for influenza vaccine efficacy evaluation. As an additional method for 150 volunteers (50 volunteers in each group), a microneutralization assay is planned (the data will be used to evaluate seroprotection). Seroprotection: share of subjects achieving protective antibody titer (1:40 and more, assessed by HAIR and microneutralization test) to antigens H1N1, H3N2, Yamagata and Victoria lineages.
Measured: Day 21 after immunization (Visit 7)
Incidence of Influenza and Acute Respiratory Infection (ARI)
Incidence of influenza and acute respiratory infection (ARI) based on assessment at Visit 11.
Measured: Day 180±5 after immunization (Visit 11)
The Average Value of the Total Duration of the Disease in Patients With Acute Respiratory Viral Infections or Influenza in Days .
A case of influenza and ARI is considered as a case of flu-like symptoms (according to: European center for Disease Prevention and Control (ECDC) TECHNICAL DOCUMENT Protocol for case-control studies to measure pandemic and seasonal influenza vaccine effectiveness in the European Union and European Economic Area Member States/ ECDC, 2009): if a subject seeks physician's advice regarding unexpected occurrence of at least one of 4 systemic symptoms: 1) chills or fever, 2) distress, 3) headache, 4) myalgia and at least one of 3 respiratory symptoms: 1) cough, 2) sore throat, 3) respiratory distress.
Study doctor will perform evaluation of influenza or ARI duration and severity, making phone calls to subject. A case with at least 1 of the complications listed below will be considered severe: the necessity of hospitalization; influenza-associated pneumonia; influenza-associated cardiovascular disorder; death.
Measured: Day 180±5 after immunization (Visit 11)
Fold Change in Geometric Mean Titer of Serum Antibodies
Fold Change in Geometric Mean Titer of Serum Antibodies (antigens H1N1,H3N2, Yamagata and Victoria lineages) based on assessment data at visit 7.
Measured: 21 days following vaccination (visit 7).
Severity of Reported Cases of Influenza and ARI.
A case of influenza and ARI is considered as a case of flu-like symptoms (according to: ECDC TECHNICAL DOCUMENT Protocol for case-control studies to measure pandemic and seasonal influenza vaccine effectiveness in the European Union and European Economic Area Member States/ European center for Disease Prevention and Control, 2009): if a subject seeks physician's advice regarding unexpected occurrence of at least one of 4 systemic symptoms: 1) chills or fever, 2) distress, 3) headache, 4) myalgia and at least one of 3 respiratory symptoms: 1) cough, 2) sore throat, 3) respiratory distress.
Study doctor will perform evaluation of influenza or ARI duration and severity, making phone calls to subject. A case with at least 1 of the complications listed below will be considered severe: the necessity of hospitalization; influenza-associated pneumonia; influenza-associated cardiovascular disorder; death.
Measured: Day 180±5 after immunization (Visit 11)
Average Time (Months) to the First Reported Episode of Influenza and ARI
Average time (months) to the first reported episode of influenza and ARI based on assessment at Visit 11.
Measured: Day 180±5 after immunization (Visit 11)
Seroprotection: Percent of Subjects Achieving Protective Antibody Titer (1:40 and More) to Antigens H1N1, H3N2, Yamagata and Victoria Lineage, Based on Assessment at Day 21 After Immunization (Additional Method of Analysis: a Microneutralization Assay)
As an additional method for 149 volunteers, a microneutralization assay is planned (the data will be used to evaluate seroprotection). Seroprotection: share of subjects achieving protective antibody titer (1:40 and more, assessed by HAIR and microneutralization test) to antigens H1N1, H3N2, Yamagata and Victoria lineages.
Measured: Day 21 after immunization (Visit 7)
Number of Participants With Symptoms of Influenza and ARI in Vaccination Groups
The presence of ARI symptoms in participants in each group is assessed throughout the study. The presence of a symptom at least once is taken into account in the analysis if the participant has several filling out of the questionnaire.
Measured: Day 180±5 (Visit 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study startNov 2016
- Primary completionJun 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- NPO Petrovax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalia Chirun, PhD, Study director, NPO PetrovaxDmitri Lioznov, PhD, Principal investigator, Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after academician I.P. Pavlova "of the Ministry of Health of the Russian Federation.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849560
- Sponsor's protocol ID
- GriQv-III-16
- Status last verified
- Aug 2024
- First submitted
- 20 Feb 2019
- Last updated
- 4 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Parallel Group Study of Safety, Reactogenicity, Immunogenicity, and Efficacy of Quadrivalent Influenza Vaccine Grippol Quadri and Trivalent Influenza Vaccine Grippol Plus in Volunteers.
- ClinicalTrials.gov ID
- NCT03849560
- Acronym / sponsor ID
- GriQv-III-16
- Conditions
- Influenza
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- NPO PetrovaxIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Posted 4 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study to assess the safety, reactogenicity, immunogenicity, and efficacy of quadrivalent inactivated subunit influenza vaccine Grippol® Quadri (NPO Petrovax Pharm, LLC, Russia) versus trivalent inactivated polymer-subunit vaccine Grippol® Plus (NPO Petrovax Pharm, LLC, Russia) in subjects from 18 to 60 years old.
Detailed description
The first Russian quadrivalent influenza vaccine was developed to improve the effectiveness of vaccination and the cost-effectiveness of preventive immunization.
Task of the study:
- Study and comparative assessment of the immunogenicity of the influenza quadrivalent inactivated subunit Grippol® Quadri vaccine in comparison with the trivalent inactivated polymer-subunit influenza vaccine Grippol® plus in volunteers aged 18-60 years.
- Evaluation of the safety and reactogenicity of the influenza quadrivalent inactivated subunit Grippol® Quadri vaccine in comparison with the trivalent inactivated polymer-subunit influenza vaccine Grippol® plus in volunteers aged 18-60 years.
- Study and comparative evaluation of the efficacy of the influenza quadrivalent inactivated subunit Grippol® Quadri vaccine in comparison with the trivalent inactivated polymer-subunit influenza vaccine Grippol® plus in volunteers aged 18-60 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grippol® Quadri | Experimental | Biological: Grippol® QuadriGrippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose) Active ingredients: * type A (H1N1) influenza virus antigen 5 µg; * type A (H3N2) influenza virus antigen 5 µg; * type B (Yamagata lineage) influenza virus antigen 5 µg; * type B (Victoria lineage) influenza virus antigen 5 µg; * immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg. |
| Grippol® Plus, trivalent (Yamagata lineage) | Active comparator | Biological: Grippol® Plus, trivalent (Yamagata lineage)Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose) Active ingredients: * type A (H1N1) influenza virus antigen 5 µg; * type A (H3N2) influenza virus antigen 5 µg; * type B (Yamagata lineage) influenza virus antigen 5 µg; * immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg. |
| Grippol® Plus, trivalent (Victoria lineage) | Active comparator | Biological: Grippol® Plus, trivalent (Victoria lineage)Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose) Active ingredients: * type A (H1N1) influenza virus antigen 5 µg; * type A (H3N2) influenza virus antigen 5 µg; * type B (Victoria lineage) influenza virus antigen 5 µg; * immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (41 listed)
- Signed and dated volunteer's informed consent for participation in the study.
- Men and women from 18 to 60 years old.
- Healthy volunteers without signs of acute or chronic disorders, without history of chronic respiratory, cardiovascular, nervous system disorders, hepatic or renal disorders.
- Previously not immunized, or previous influenza immunization occurring ≥ 12 months before this study.
- Subjects without history of influenza within ≥ 12 months before this study.
Key exclusion criteria (8 listed)
- Informed consent recall.
- Occurrence of a severe adverse events (AE) or serious adverse events.
- The volunteer is found to meet any of the non-inclusion criteria related to the safety of the volunteer participation in the study.
- If a female-volunteer becomes pregnant.
- The volunteer takes medicines not allowed in this study.
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 |
|---|---|---|
| Grippol® QuadriSingle intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Quadri into the upper third of the outer surface of the shoulder (the deltoid muscle). | Biological | Grippol® Quadri |
| Grippol® Plus, trivalent (Yamagata lineage)Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Plus, trivalent (Yamagata lineage) into the upper third of the outer surface of the shoulder (the deltoid muscle). | Biological | Grippol® Plus, trivalent (Yamagata lineage) |
| Grippol® Plus, trivalent (Victoria lineage)Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Plus, trivalent (Victoria lineage) into the upper third of the outer surface of the shoulder (the deltoid muscle). | Biological | Grippol® Plus, trivalent (Victoria lineage) |
Primary outcome
Percent of Subjects Achieving Seroconversion Increased More Than 4-fold Versus Baseline for Antigens: Influenza Virus Type А - H1N1, Influenza Virus Type А - H3N2, Influenza Virus Type В - Yamagata and Victoria Lineage
Time frame: Day 21 after immunization (Visit 7)
Percent of subjects achieving seroconversion (the number of volunteers with antibody titer [of at least 1:40] increased more than 4-fold versus baseline [assessed by HAIR]) for antigens: influenza virus type А - H1N1, influenza virus type А - H3N2, influenza virus type В - Yamagata and Victoria lineage, based on assessment at Visit 7.
9 secondary outcomes
Geometric Mean of Serum Antibodies
Time frame: Day 21 after immunization (Visit 7)
Seroprotection: Percent of Subjects Achieving Protective Antibody Titer (1:40 and More) to Antigens H1N1, H3N2, Yamagata and Victoria Lineage, Based on Assessment at Day 21 After Immunization (Visit 7).
Time frame: Day 21 after immunization (Visit 7)
Incidence of Influenza and Acute Respiratory Infection (ARI)
Time frame: Day 180±5 after immunization (Visit 11)
The Average Value of the Total Duration of the Disease in Patients With Acute Respiratory Viral Infections or Influenza in Days .
Time frame: Day 180±5 after immunization (Visit 11)
Fold Change in Geometric Mean Titer of Serum Antibodies
Time frame: 21 days following vaccination (visit 7).
Severity of Reported Cases of Influenza and ARI.
Time frame: Day 180±5 after immunization (Visit 11)
Average Time (Months) to the First Reported Episode of Influenza and ARI
Time frame: Day 180±5 after immunization (Visit 11)
Seroprotection: Percent of Subjects Achieving Protective Antibody Titer (1:40 and More) to Antigens H1N1, H3N2, Yamagata and Victoria Lineage, Based on Assessment at Day 21 After Immunization (Additional Method of Analysis: a Microneutralization Assay)
Time frame: Day 21 after immunization (Visit 7)
Number of Participants With Symptoms of Influenza and ARI in Vaccination Groups
Time frame: Day 180±5 (Visit 11)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Natalia Chirun, PhD study director
NPO Petrovax
Dmitri Lioznov, PhD principal investigator
Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after academician I.P. Pavlova "of the Ministry of Health of the Russian Federation.
3 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 Grippol® Quadri, Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) in people with Influenza, run by NPO Petrovax at 3 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 41 inclusion and 8 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 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 4 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Subjects Achieving Seroconversion Increased More Than 4-fold Versus Baseline for Antigens: Influenza Virus Type А - H1N1, Influenza Virus Type А - H3N2, Influenza Virus Type В - Yamagata and Victoria Lineage (time frame: Day 21 after immunization (Visit 7)). 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 4 Nov 2024.