Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-28 @ 8:45 PM
Study NCT ID:
NCT03849560
Status:
COMPLETED
Last Update Posted:
2024-11-04
First Post:
2019-02-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Reactogenicity, Immunogenicity, Efficacy of Influenza Vaccines Grippol® Quadri and Grippol® Plus in Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DodonovNS@petrovax.ru', 'phone': '+7(495) 730-75-45', 'title': 'Nikolay Dodonov, Head of medical department', 'phoneExt': '125', 'organization': 'NPO Petrovax Pharm, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '180±5 Days', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Grippol® Quadri', 'description': 'Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).', 'otherNumAtRisk': 205, 'deathsNumAtRisk': 205, 'otherNumAffected': 90, 'seriousNumAtRisk': 205, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Grippol® Plus, Trivalent (Yamagata Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).', 'otherNumAtRisk': 205, 'deathsNumAtRisk': 205, 'otherNumAffected': 92, 'seriousNumAtRisk': 205, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Grippol® Plus, Trivalent (Victoria Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).', 'otherNumAtRisk': 202, 'deathsNumAtRisk': 202, 'otherNumAffected': 93, 'seriousNumAtRisk': 202, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Furunculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Herpes in the nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 74}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dysmenorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Кашель', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pharyngeal erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Grippol® Quadri', 'description': 'Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG001', 'title': 'Grippol® Plus, Trivalent (Yamagata Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG002', 'title': 'Grippol® Plus, Trivalent (Victoria Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}], 'classes': [{'title': 'H1N1', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}]}, {'title': 'Victoria (VICT)', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}]}, {'title': 'Yamagata (YAMA)', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.82', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Odds ratio was calculated to compare seroconversion for antigen H1N1 in group Grippol® Quadri and groups Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage)'}, {'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '1.08', 'ciUpperLimit': '2.30', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': '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)'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '0.90', 'ciUpperLimit': '2.15', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Odds ratio was calculated to compare seroconversion for YAMA antigen in group Grippol® Quadri and group Grippol® Plus, trivalent (Yamagata lineage)'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.63', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Odds ratio was calculated to compare seroconversion for VICT antigen in group Grippol® Quadri and group Grippol® Plus, trivalent (Victoria lineage)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 21 after immunization (Visit 7)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Geometric Mean of Serum Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Grippol® Quadri', 'description': 'Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG001', 'title': 'Grippol® Plus, Trivalent (Yamagata Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG002', 'title': 'Grippol® Plus, Trivalent (Victoria Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}], 'classes': [{'title': 'H1N1', 'categories': [{'measurements': [{'value': '102.30', 'groupId': 'OG000', 'lowerLimit': '89.54', 'upperLimit': '116.95'}, {'value': '87.39', 'groupId': 'OG001', 'lowerLimit': '76.75', 'upperLimit': '99.77'}, {'value': '94.32', 'groupId': 'OG002', 'lowerLimit': '82.60', 'upperLimit': '107.65'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '70.99', 'groupId': 'OG000', 'lowerLimit': '60.95', 'upperLimit': '82.60'}, {'value': '56.95', 'groupId': 'OG001', 'lowerLimit': '48.98', 'upperLimit': '66.22'}, {'value': '62.06', 'groupId': 'OG002', 'lowerLimit': '53.33', 'upperLimit': '72.28'}]}]}, {'title': 'VICT', 'categories': [{'measurements': [{'value': '41.39', 'groupId': 'OG000', 'lowerLimit': '35.97', 'upperLimit': '47.53'}, {'value': '17.05', 'groupId': 'OG001', 'lowerLimit': '14.83', 'upperLimit': '19.59'}, {'value': '47.65', 'groupId': 'OG002', 'lowerLimit': '41.40', 'upperLimit': '54.83'}]}]}, {'title': 'YAMA', 'categories': [{'measurements': [{'value': '65.63', 'groupId': 'OG000', 'lowerLimit': '57.15', 'upperLimit': '75.51'}, {'value': '52.85', 'groupId': 'OG001', 'lowerLimit': '46.03', 'upperLimit': '60.67'}, {'value': '34.87', 'groupId': 'OG002', 'lowerLimit': '30.34', 'upperLimit': '40.09'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8933', 'ciLowerLimit': '0.7762', 'ciUpperLimit': '1.030', 'groupDescription': 'Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) for the strain A/H1N1', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) vaccines for the strain A/H1N1 if the upper limit of the two-sided 95% Confidence Interval (CI) of the ratio of means of geometric antibody titers for H1N1 was ≤1.5'}, {'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8913', 'ciLowerLimit': '0.7516', 'ciUpperLimit': '1.0593', 'groupDescription': 'Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) for the strain A/H3N2', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) vaccines for the strain A/H3N2 if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for H3N2 was ≤1.5'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8185', 'ciLowerLimit': '0.6918', 'ciUpperLimit': '0.9683', 'groupDescription': 'Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) for the strain B/Yamagata', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) vaccine for the strain B/Yamagata if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for Yamagata antigen was ≤1'}, {'pValue': '0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0328', 'ciLowerLimit': '0.8570', 'ciUpperLimit': '1.2445', 'groupDescription': 'Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Victoria lineage) for the strain B/Victoria', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Victoria lineage) vaccine for the strain B/Victoria if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for Victoria antigen was ≤1'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 21 after immunization (Visit 7)', 'description': 'To antigens: influenza virus type А - H1N1, influenza virus type А - H3N2, influenza virus type В - Yamagata and Victoria lineage.\n\nBased on assessment at Visit 7.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Grippol® Quadri', 'description': 'Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG001', 'title': 'Grippol® Plus, Trivalent (Yamagata Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG002', 'title': 'Grippol® Plus, Trivalent (Victoria Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}], 'classes': [{'title': 'H1N1 before vaccination (Baseline)', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'H1N1 day 21 after vaccination', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}]}, {'title': 'H3N2 before vaccination (Baseline)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}, {'title': 'H3N2 day 21 after vaccination', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}]}, {'title': 'Yamagata before vaccination (Baseline)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}, {'title': 'Yamagata day 21 after vaccination', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}]}, {'title': 'Victoria before vaccination (Baseline)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Victoria day 21 after vaccination', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.758', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Seroprotection for strain A/H1N1 in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage) groups'}, {'pValue': '0.282', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Seroprotection for strain A/H3N2 in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage) groups'}, {'pValue': '0.352', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Seroprotection for strain B/Yamagata in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage) group'}, {'pValue': '0.815', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Seroprotection for strain B/Victoria in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Victoria lineage) group'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 21 after immunization (Visit 7)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Incidence of Influenza and Acute Respiratory Infection (ARI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Grippol® Quadri', 'description': 'Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG001', 'title': 'Grippol® Plus, Trivalent (Yamagata Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG002', 'title': 'Grippol® Plus, Trivalent (Victoria Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.452', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.639', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 180±5 after immunization (Visit 11)', 'description': 'Incidence of influenza and acute respiratory infection (ARI) based on assessment at Visit 11.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'The Average Value of the Total Duration of the Disease in Patients With Acute Respiratory Viral Infections or Influenza in Days .', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Grippol® Quadri', 'description': 'Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG001', 'title': 'Grippol® Plus, Trivalent (Yamagata Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG002', 'title': 'Grippol® Plus, Trivalent (Victoria Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.00', 'spread': '4.743', 'groupId': 'OG000'}, {'value': '8.05', 'spread': '5.350', 'groupId': 'OG001'}, {'value': '9.61', 'spread': '7.086', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 180±5 after immunization (Visit 11)', 'description': "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.\n\nStudy 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.", 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall Number of Participants Analyzed here represents the number of participants with incidence of Influenza and ARI'}, {'type': 'SECONDARY', 'title': 'Fold Change in Geometric Mean Titer of Serum Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Grippol® Quadri', 'description': 'Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG001', 'title': 'Grippol® Plus, Trivalent (Yamagata Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG002', 'title': 'Grippol® Plus, Trivalent (Victoria Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}], 'classes': [{'title': 'H1N1', 'categories': [{'measurements': [{'value': '4.86', 'groupId': 'OG000', 'lowerLimit': '4.22', 'upperLimit': '5.60'}, {'value': '4.21', 'groupId': 'OG001', 'lowerLimit': '3.59', 'upperLimit': '4.94'}, {'value': '4.60', 'groupId': 'OG002', 'lowerLimit': '3.97', 'upperLimit': '5.34'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '5.32', 'groupId': 'OG000', 'lowerLimit': '4.53', 'upperLimit': '6.24'}, {'value': '5.22', 'groupId': 'OG001', 'lowerLimit': '4.45', 'upperLimit': '6.12'}, {'value': '5.17', 'groupId': 'OG002', 'lowerLimit': '4.38', 'upperLimit': '6.12'}]}]}, {'title': 'VICT', 'categories': [{'measurements': [{'value': '4.77', 'groupId': 'OG000', 'lowerLimit': '4.14', 'upperLimit': '5.49'}, {'value': 'NA', 'comment': "Grippol® Plus, trivalent (Yamagata lineage) didn't contain Victoria lineage", 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.72', 'groupId': 'OG002', 'lowerLimit': '4.00', 'upperLimit': '5.56'}]}]}, {'title': 'YAMA', 'categories': [{'measurements': [{'value': '5.47', 'groupId': 'OG000', 'lowerLimit': '4.78', 'upperLimit': '6.25'}, {'value': '4.04', 'groupId': 'OG001', 'lowerLimit': '3.48', 'upperLimit': '4.96'}, {'value': 'NA', 'comment': "Grippol® Plus, trivalent (Victoria lineage) didn't contain Yamagata lineage", 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Coefficient of increase of mean geometri', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.86', 'ciLowerLimit': '4.22', 'ciUpperLimit': '5.60', 'groupDescription': 'Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Quadri group', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5'}, {'groupIds': ['OG000'], 'paramType': 'Coefficient of increase of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.32', 'ciLowerLimit': '4.53', 'ciUpperLimit': '6.24', 'groupDescription': 'Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Quadri group', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5'}, {'groupIds': ['OG000'], 'paramType': 'Coefficient of increase of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.47', 'ciLowerLimit': '4.78', 'ciUpperLimit': '6.25', 'groupDescription': 'Coefficient of increase of mean geometric antibody titer for Yamagata in Grippol® Quadri group', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Yamagata should be ˃ 2.5'}, {'groupIds': ['OG000'], 'paramType': 'Coefficient of increase of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.77', 'ciLowerLimit': '4.14', 'ciUpperLimit': '5.49', 'groupDescription': 'Coefficient of increase of mean geometric antibody titer for Victoria in Grippol® Quadri group', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Victoria should be ˃ 2.5'}, {'groupIds': ['OG001'], 'paramType': 'Coefficient of increase of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.21', 'ciLowerLimit': '3.59', 'ciUpperLimit': '4.94', 'groupDescription': 'Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Plus, trivalent (Yamagata lineage) group', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5'}, {'groupIds': ['OG001'], 'paramType': 'Coefficient of increase of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.22', 'ciLowerLimit': '4.45', 'ciUpperLimit': '6.12', 'groupDescription': 'Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Plus, trivalent (Yamagata lineage) group', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5'}, {'groupIds': ['OG001'], 'paramType': 'Coefficient of increase of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.04', 'ciLowerLimit': '3.48', 'ciUpperLimit': '4.69', 'groupDescription': 'Coefficient of increase of mean geometric antibody titer for Yamagata in Grippol® Plus, trivalent (Yamagata lineage) group', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Yamagata should be ˃ 2.5'}, {'groupIds': ['OG002'], 'paramType': 'Coefficient of increase of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.60', 'ciLowerLimit': '3.97', 'ciUpperLimit': '5.34', 'groupDescription': 'Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Plus, trivalent (Victoria lineage) group', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5'}, {'groupIds': ['OG002'], 'paramType': 'Coefficient of increase of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.17', 'ciLowerLimit': '4.38', 'ciUpperLimit': '6.12', 'groupDescription': 'Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Plus, trivalent (Victoria lineage) group', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5'}, {'groupIds': ['OG002'], 'paramType': 'Coefficient of increase of GMT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.72', 'ciLowerLimit': '4.00', 'ciUpperLimit': '5.56', 'groupDescription': 'Coefficient of increase of mean geometric antibody titer for Victoria in Grippol® Plus, trivalent (Victoria lineage) group', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Victoria should be ˃ 2.5'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '21 days following vaccination (visit 7).', 'description': 'Fold Change in Geometric Mean Titer of Serum Antibodies (antigens H1N1,H3N2, Yamagata and Victoria lineages) based on assessment data at visit 7.', 'unitOfMeasure': 'Ratio of geometric means', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Severity of Reported Cases of Influenza and ARI.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Grippol® Quadri', 'description': 'Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG001', 'title': 'Grippol® Plus, Trivalent (Yamagata Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG002', 'title': 'Grippol® Plus, Trivalent (Victoria Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}], 'classes': [{'title': 'mild', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'moderate', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 180±5 after immunization (Visit 11)', 'description': "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.\n\nStudy 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.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall Number of Participants Analyzed here represents the number of participants with incidence of Influenza and ARI'}, {'type': 'SECONDARY', 'title': 'Average Time (Months) to the First Reported Episode of Influenza and ARI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Grippol® Quadri', 'description': 'Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG001', 'title': 'Grippol® Plus, Trivalent (Yamagata Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG002', 'title': 'Grippol® Plus, Trivalent (Victoria Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.626', 'groupId': 'OG000', 'lowerLimit': '4.319', 'upperLimit': '4.934'}, {'value': '5.111', 'groupId': 'OG001', 'lowerLimit': '4.836', 'upperLimit': '5.385'}, {'value': '4.819', 'groupId': 'OG002', 'lowerLimit': '4.529', 'upperLimit': '5.110'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 180±5 after immunization (Visit 11)', 'description': 'Average time (months) to the first reported episode of influenza and ARI based on assessment at Visit 11.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': '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)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Grippol® Quadri', 'description': 'Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG001', 'title': 'Grippol® Plus, Trivalent (Yamagata Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG002', 'title': 'Grippol® Plus, Trivalent (Victoria Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}], 'classes': [{'title': 'H1N1', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'H3N2', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Yamagata', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Victoria', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 21 after immunization (Visit 7)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Additional method of analysis only for 149 volunteers'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Symptoms of Influenza and ARI in Vaccination Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Grippol® Quadri', 'description': 'Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG001', 'title': 'Grippol® Plus, Trivalent (Yamagata Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'OG002', 'title': 'Grippol® Plus, Trivalent (Victoria Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}], 'classes': [{'title': 'Sore throat', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory difficulty', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Feeling of being unwell', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}, {'title': 'Chills or fever', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 180±5 (Visit 11)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall Number of Participants Analyzed here represents the number of participants with incidence of Influenza and ARI;'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Grippol® Quadri', 'description': 'Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'FG001', 'title': 'Grippol® Plus, Trivalent (Yamagata Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'FG002', 'title': 'Grippol® Plus, Trivalent (Victoria Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}, {'groupId': 'FG001', 'numSubjects': '205'}, {'groupId': 'FG002', 'numSubjects': '202'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '205'}, {'groupId': 'FG002', 'numSubjects': '202'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '612', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Grippol® Quadri', 'description': 'Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'BG001', 'title': 'Grippol® Plus, Trivalent (Yamagata Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'BG002', 'title': 'Grippol® Plus, Trivalent (Victoria Lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.\n\nGrippol® 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).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '612', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '28.37', 'spread': '10.15', 'groupId': 'BG000'}, {'value': '28.97', 'spread': '10.48', 'groupId': 'BG001'}, {'value': '29.29', 'spread': '10.55', 'groupId': 'BG002'}, {'value': '28.87', 'spread': '10.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '612', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '335', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '277', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '612', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '612', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '612', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '171.9', 'spread': '9.18', 'groupId': 'BG000'}, {'value': '172.0', 'spread': '9.28', 'groupId': 'BG001'}, {'value': '172.3', 'spread': '9.45', 'groupId': 'BG002'}, {'value': '172.1', 'spread': '9.29', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '612', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '68.3', 'spread': '12.23', 'groupId': 'BG000'}, {'value': '68.7', 'spread': '12.41', 'groupId': 'BG001'}, {'value': '68.7', 'spread': '11.97', 'groupId': 'BG002'}, {'value': '68.5', 'spread': '12.19', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '612', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '22.97', 'spread': '2.86', 'groupId': 'BG000'}, {'value': '23.09', 'spread': '2.90', 'groupId': 'BG001'}, {'value': '23.04', 'spread': '3.08', 'groupId': 'BG002'}, {'value': '23.03', 'spread': '2.94', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': '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.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-18', 'size': 1124494, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-21T03:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 612}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2019-02-20', 'resultsFirstSubmitDate': '2019-03-01', 'studyFirstSubmitQcDate': '2019-02-20', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-21', 'studyFirstPostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'Day 21 after immunization (Visit 7)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean of Serum Antibodies', 'timeFrame': 'Day 21 after immunization (Visit 7)', 'description': 'To antigens: influenza virus type А - H1N1, influenza virus type А - H3N2, influenza virus type В - Yamagata and Victoria lineage.\n\nBased on assessment at Visit 7.'}, {'measure': '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).', 'timeFrame': 'Day 21 after immunization (Visit 7)', 'description': '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.'}, {'measure': 'Incidence of Influenza and Acute Respiratory Infection (ARI)', 'timeFrame': 'Day 180±5 after immunization (Visit 11)', 'description': 'Incidence of influenza and acute respiratory infection (ARI) based on assessment at Visit 11.'}, {'measure': 'The Average Value of the Total Duration of the Disease in Patients With Acute Respiratory Viral Infections or Influenza in Days .', 'timeFrame': 'Day 180±5 after immunization (Visit 11)', 'description': "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.\n\nStudy 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."}, {'measure': 'Fold Change in Geometric Mean Titer of Serum Antibodies', 'timeFrame': '21 days following vaccination (visit 7).', 'description': 'Fold Change in Geometric Mean Titer of Serum Antibodies (antigens H1N1,H3N2, Yamagata and Victoria lineages) based on assessment data at visit 7.'}, {'measure': 'Severity of Reported Cases of Influenza and ARI.', 'timeFrame': 'Day 180±5 after immunization (Visit 11)', 'description': "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.\n\nStudy 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."}, {'measure': 'Average Time (Months) to the First Reported Episode of Influenza and ARI', 'timeFrame': 'Day 180±5 after immunization (Visit 11)', 'description': 'Average time (months) to the first reported episode of influenza and ARI based on assessment at Visit 11.'}, {'measure': '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)', 'timeFrame': 'Day 21 after immunization (Visit 7)', 'description': '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.'}, {'measure': 'Number of Participants With Symptoms of Influenza and ARI in Vaccination Groups', 'timeFrame': 'Day 180±5 (Visit 11)', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The first Russian quadrivalent influenza vaccine was developed to improve the effectiveness of vaccination and the cost-effectiveness of preventive immunization.\n\nTask of the study:\n\n1. 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.\n2. 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.\n3. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed and dated volunteer's informed consent for participation in the study.\n2. Men and women from 18 to 60 years old.\n3. Healthy volunteers without signs of acute or chronic disorders, without history of chronic respiratory, cardiovascular, nervous system disorders, hepatic or renal disorders.\n4. Previously not immunized, or previous influenza immunization occurring ≥ 12 months before this study.\n5. Subjects without history of influenza within ≥ 12 months before this study.\n6. 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.\n\nSpecific:\n\n1. Contraindications listed in the protocol and prescribing information for inactivated influenza vaccines:\n\n * 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;\n * hepatitis or meningococcal infection occurred less than 6 months after recovery;\n * 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);\n * malignant neoplasms (including hematological disorders);\n * primary immunodeficiency (laboratory-confirmed);\n * HIV infection or HIV-associated disorders;\n * systemic disorders of connective tissue;\n * haemophilia (and other blood coagulation disorders);\n * severe neurological disorders;\n * 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);\n * 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);\n * history of severe allergic disorders (angioedema, polymorphic exudative erythema, serum disease, etc.);\n * hypersensitivity to chicken protein or vaccine components;\n * blood and components transfusion within the last 6 months.\n2. Indications for immunomodulating therapy.\n3. Body temperature over 37.0 °С at screening or before injection.\n4. Potential evidence of a chronic infection (periodic episodes of fever within the last 6 months), or antiviral (and/or antibacterial) treatment indicated.\n5. 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\\]).\n6. Use of antipyretics (including non-steroidal anti-inflammatory drugs and anilides) within 24 hours before randomization.\n7. Surgical interventions within less than 90 days before the screening visit.\n8. 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.\n9. 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.\n\n General:\n10. Pregnant and nursing women.\n11. Lack of ability to visit daytime inpatient facility according to the study schedule, unavailability for adequate follow-up of the volunteer.\n12. Body mass index of less than 18.5 or over 30.0 kg/m2 based on the weight-height Quetelet's index.\n13. Participation in another clinical study of medicinal drugs within 3 months before the start of this study.\n14. Mental, physical, or other reasons which prevent adequate assessment of own behavior and prevent from meeting the study protocol conditions.\n15. History of narcotic and/or drug abuse, and/or inhalant addiction, current signs of alcoholic intoxication.\n16. 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.\n17. Suspected lack of compliance with treatment or inability to undergo treatment and observe the limitations according to the study protocol.\n18. Volunteers acknowledged by the court to be disabled or under guardianship.\n19. Any other conditions that make the volunteer ineligible for the study according to a justified opinion of the study doctor or Sponsor.\n\nExclusion Criteria:\n\n* Informed consent recall.\n* Occurrence of a severe adverse events (AE) or serious adverse events.\n* The volunteer is found to meet any of the non-inclusion criteria related to the safety of the volunteer participation in the study.\n* If a female-volunteer becomes pregnant.\n* The volunteer takes medicines not allowed in this study.\n* The volunteer is lost to follow-up.\n* In a situation, which, to the investigator's judgment, may adversely impact the volunteer if he/she continues participating in the study.\n* 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."}, 'identificationModule': {'nctId': 'NCT03849560', 'briefTitle': 'Safety, Reactogenicity, Immunogenicity, Efficacy of Influenza Vaccines Grippol® Quadri and Grippol® Plus in Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'NPO Petrovax'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'GriQv-III-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Grippol® Quadri', 'description': 'Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.', 'interventionNames': ['Biological: Grippol® Quadri']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Grippol® Plus, trivalent (Yamagata lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Yamagata lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.', 'interventionNames': ['Biological: Grippol® Plus, trivalent (Yamagata lineage)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Grippol® Plus, trivalent (Victoria lineage)', 'description': 'Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen.\n\nDosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose)\n\nActive ingredients:\n\n* type A (H1N1) influenza virus antigen 5 µg;\n* type A (H3N2) influenza virus antigen 5 µg;\n* type B (Victoria lineage) influenza virus antigen 5 µg;\n* immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.', 'interventionNames': ['Biological: Grippol® Plus, trivalent (Victoria lineage)']}], 'interventions': [{'name': 'Grippol® Quadri', 'type': 'BIOLOGICAL', 'description': '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).', 'armGroupLabels': ['Grippol® Quadri']}, {'name': 'Grippol® Plus, trivalent (Yamagata lineage)', 'type': 'BIOLOGICAL', 'description': '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).', 'armGroupLabels': ['Grippol® Plus, trivalent (Yamagata lineage)']}, {'name': 'Grippol® Plus, trivalent (Victoria lineage)', 'type': 'BIOLOGICAL', 'description': '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).', 'armGroupLabels': ['Grippol® Plus, trivalent (Victoria lineage)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '197022', 'city': 'Saint Petersburg', 'state': "Leningradskaya Oblast'", 'country': 'Russia', 'facility': '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.'}, {'zip': '197022', 'city': 'Saint Petersburg', 'state': "Leningradskaya Oblast'", 'country': 'Russia', 'facility': 'Federal State Budgetary Institution "Children\'s Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency"'}, {'zip': '197376', 'city': 'Saint Petersburg', 'state': "Leningradskaya Oblast'", 'country': 'Russia', 'facility': 'Smorodintsev Research Institute of Influenza'}], 'overallOfficials': [{'name': 'Natalia Chirun, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NPO Petrovax'}, {'name': 'Dmitri Lioznov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '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.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NPO Petrovax', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}