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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
|
| 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:
|
|
| 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grippol® Quadri | Biological | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 21 after immunization (Visit 7) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
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Inclusion Criteria:
Specific:
Contraindications listed in the protocol and prescribing information for inactivated influenza vaccines:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalia Chirun, PhD | NPO Petrovax | Study Director |
| Dmitri Lioznov, PhD | 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. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Grippol® Quadri | Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose) Active ingredients:
Grippol® Quadri: 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2016 |
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| 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). |
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 180±5 (Visit 11) |
| Russia |
| 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 | Russia |
| Smorodintsev Research Institute of Influenza | Saint Petersburg | Leningradskaya Oblast' | 197376 | Russia |
| FG001 | 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:
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). |
| FG002 | 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:
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). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
612 patients were randomized, 1 patient dropped out during the trial (due to withdrawal of informed consent), data of these patients were used for safety analysis. 611 patients completed the study, data from 607 participants were accepted for the final analysis of immunological efficacy (4 patients were excluded from the analysis due to lack of baseline values for analysis of immunological efficacy), data from 609 participants were used for analysis of secondary outcome measures.
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| ID | Title | Description |
|---|---|---|
| BG000 | Grippol® Quadri | Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose) Active ingredients:
Grippol® Quadri: 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). |
| BG001 | 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:
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). |
| BG002 | 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:
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). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||
| Height | Mean | Standard Deviation | centimeters |
| ||||||||||
| Weight | Mean | Standard Deviation | kilograms |
| ||||||||||
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 612 patients were randomized, 1 people dropped out during the trial (due to withdrawal of informed consent). 611 patients completed the study, data from 607 participants were accepted for the final analysis of efficacy (4 patients were excluded from the analysis due to the lack of baseline values for analysis of immunological efficacy). | Posted | Count of Participants | Participants | Day 21 after immunization (Visit 7) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 612 patients were randomized, 1 patient dropped out during the trial, data of these patients were used for safety analysis. 611 patients completed the study (FAS), data from 607 participants were accepted for the final analysis of immunological efficacy - primary outcome measure (4 patients were excluded from the analysis due to lack of baseline values for analysis of immunological efficacy), data from 609 participants were used for analysis of secondary outcome measures. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 21 after immunization (Visit 7) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 612 patients were randomized, 1 patient dropped out during the trial, data of these patients were used for safety analysis. 611 patients completed the study (FAS), data from 607 participants were accepted for the final analysis of immunological efficacy - primary outcome measure (4 patients were excluded from the analysis due to lack of baseline values for analysis of immunological efficacy), data from 609 participants were used for analysis of secondary outcome measures. | Posted | Count of Participants | Participants | Day 21 after immunization (Visit 7) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Influenza and Acute Respiratory Infection (ARI) | Incidence of influenza and acute respiratory infection (ARI) based on assessment at Visit 11. | 612 patients were randomized, 1 patient dropped out during the trial (due to withdrawal of informed consent).There were data for this parametr only from 610 patients (1 patient dropped out during the trial, data for another patient is absent for unknown reason). | Posted | Count of Participants | Participants | Day 180±5 after immunization (Visit 11) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Overall Number of Participants Analyzed here represents the number of participants with incidence of Influenza and ARI | Posted | Mean | Standard Deviation | days | Day 180±5 after immunization (Visit 11) |
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| Secondary | 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. | 612 patients were randomized, 1 patient dropped out during the trial, data of these patients were used for safety analysis. 611 patients completed the study, data from 607 participants were accepted for the final analysis of immunological efficacy - primary outcome measure (4 patients were excluded from the analysis due to lack of baseline values for analysis of immunological efficacy), data from 609 participants were used for analysis of secondary outcome measures. | Posted | Geometric Mean | 95% Confidence Interval | Ratio of geometric means | 21 days following vaccination (visit 7). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Overall Number of Participants Analyzed here represents the number of participants with incidence of Influenza and ARI | Posted | Count of Participants | Participants | Day 180±5 after immunization (Visit 11) |
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| Secondary | 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. | 612 patients were randomized, 1 patient dropped out during the trial (due to withdrawal of informed consent).There were data for this parameter only from 610 patients (1 patient dropped out during the trial, data for another patient is absent for unknown reason). | Posted | Mean | 95% Confidence Interval | months | Day 180±5 after immunization (Visit 11) |
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| Secondary | 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. | Additional method of analysis only for 149 volunteers | Posted | Count of Participants | Participants | Day 21 after immunization (Visit 7) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Overall Number of Participants Analyzed here represents the number of participants with incidence of Influenza and ARI; | Posted | Count of Participants | Participants | Day 180±5 (Visit 11) |
|
180±5 Days
No serious adverse events (SAE) or AEs leading to withdrawal from the study were reported after phase 1 study. There were no cases of SAE or death during the current phase 2-3 study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Grippol® Quadri | Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose) Active ingredients:
Grippol® Quadri: 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). | 0 | 205 | 0 | 205 | 90 | 205 |
| EG001 | 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:
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). | 0 | 205 | 0 | 205 | 92 | 205 |
| EG002 | 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:
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). | 0 | 202 | 0 | 202 | 93 | 202 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fever | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Furunculosis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Herpes in the nose | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute pyelonephritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Кашель | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nikolay Dodonov, Head of medical department | NPO Petrovax Pharm, LLC | +7(495) 730-75-45 | 125 | DodonovNS@petrovax.ru |
| Feb 21, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| Title | Measurements |
|---|---|
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| Victoria (VICT) |
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| Yamagata (YAMA) |
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| Odds Ratio, log |
| 1.54 |
| 2-Sided |
| 95 |
| 1.08 |
| 2.30 |
| Non-Inferiority |
Odds ratio was calculated to compare seroconversion for antigen H3N2 in group Grippol® Quadri and groups Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage) |
| Odds Ratio, log | 1.39 | 2-Sided | 95 | 0.90 | 2.15 | Non-Inferiority | Odds ratio was calculated to compare seroconversion for YAMA antigen in group Grippol® Quadri and group Grippol® Plus, trivalent (Yamagata lineage) |
| Odds Ratio, log | 1.05 | 2-Sided | 95 | 0.68 | 1.63 | Non-Inferiority | Odds ratio was calculated to compare seroconversion for VICT antigen in group Grippol® Quadri and group Grippol® Plus, trivalent (Victoria 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:
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).
| OG002 | 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:
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). |
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| OG001 | 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:
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). |
| OG002 | 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:
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). |
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| OG002 | 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:
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). |
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| OG001 | 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:
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). |
| OG002 | 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:
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). |
|
|
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:
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). |
| OG002 | 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:
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). |
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| OG001 | 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:
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). |
| OG002 | 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:
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). |
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|
| OG002 | 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:
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). |
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| OG002 | 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:
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). |
|
|
| OG002 | 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:
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). |
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