Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-28 @ 2:29 PM
Study NCT ID:
NCT02387294
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2014-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection for Children and Adolescents
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014611', 'term': 'Vaccination'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D016233', 'term': 'Immunotherapy, Active'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011322', 'term': 'Primary Prevention'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003140', 'term': 'Communicable Disease Control'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@fluart.hu', 'phone': '+3620', 'title': 'Zsolt Németh', 'phoneExt': '4197020', 'organization': 'Fluart Innovative Vaccines Ltd'}, 'certainAgreement': {'otherDetails': 'The disclosure restriction on the PI is that the sponsor in the frames of the general confidentiality agreement is that the PI cannot release any information concenning the study without the prior consent of the sponsor. To further specification is provided.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '21-28 days after vaccination', 'description': 'Diary card was used by all subjects to record Adverse Events between Day 0-7 (during 7 days after vaccination), afterwards, Adverse Events were recorded on Day 21-28. Serious Adverse Events were reported in 24 hours after its occurrence.', 'eventGroups': [{'id': 'EG000', 'title': 'Age Group 1: Children (3-11 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 59, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Age Group 2: Adolescents (12-18 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: A single dose (0.5 ml) vaccine, administered intramuscularly.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 56, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'vaccination site pain', 'notes': 'pain at the vaccination site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'vaccination site erythema', 'notes': 'erythema at the vaccination site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'vaccination site swelling', 'notes': 'swelling at the vaccination site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'myalgia', 'notes': 'myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'malaise', 'notes': 'malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'vaccination site induration', 'notes': 'induration at vaccination site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'vaccination site haematoma', 'notes': 'haematoma at vaccination site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'chills', 'notes': 'chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'pharyngitis', 'notes': 'pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'helminthic infection', 'notes': 'helminthic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'headache', 'notes': 'headcahe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'hypersensitivity', 'notes': 'allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'cystitis', 'notes': 'cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'pyrexia', 'notes': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'cough', 'notes': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'vomiting', 'notes': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'abdominal pain', 'notes': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'syncope', 'notes': 'collapsus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'nasopharyngitis', 'notes': 'common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'oropharyngeal pain', 'notes': 'sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Increase in Geometric Mean Titre Ratio, A/H1N1 Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Age Group 1: Children (3-11 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.'}, {'id': 'OG001', 'title': 'Age Group 2: Adolescents', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: A single dose (0.5 ml) vaccine, administered intramuscularly.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.337', 'groupId': 'OG000', 'lowerLimit': '3.432', 'upperLimit': '5.480'}, {'value': '4.702', 'groupId': 'OG001', 'lowerLimit': '3.595', 'upperLimit': '6.151'}]}]}], 'paramType': 'MEAN', 'timeFrame': '21-28 days after vaccination', 'description': 'Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres\n\nRequirement: \\> 2.5', 'unitOfMeasure': 'Ratio of Day 0 and Day 21-28 titres', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)'}, {'type': 'PRIMARY', 'title': 'Increase in Geometric Mean Titre Ratio, A/H3N2 Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Age Group 1: Children (3-11 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.'}, {'id': 'OG001', 'title': 'Age Group 2: Adolescents (12-18 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: A single dose (0.5 ml) vaccine, administered intramuscularly.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.982', 'groupId': 'OG000', 'lowerLimit': '3.847', 'upperLimit': '6.451'}, {'value': '5.993', 'groupId': 'OG001', 'lowerLimit': '4.207', 'upperLimit': '8.539'}]}]}], 'paramType': 'MEAN', 'timeFrame': '21-28 days after vaccination', 'description': 'Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres\n\nRequirement: \\> 2.5', 'unitOfMeasure': 'Ratio of Day 0 and Day 21-28 antihaemagg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)'}, {'type': 'PRIMARY', 'title': 'Increase in Geometric Mean Titre Ratio, B Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Age Group 1: Children (3-11 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.'}, {'id': 'OG001', 'title': 'Age Group 2: Adolescents (12-18 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: A single dose (0.5 ml) vaccine, administered intramuscularly.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.262', 'groupId': 'OG000', 'lowerLimit': '3.383', 'upperLimit': '5.370'}, {'value': '4.757', 'groupId': 'OG001', 'lowerLimit': '3.762', 'upperLimit': '6.014'}]}]}], 'paramType': 'MEAN', 'timeFrame': '21-28 days after vaccination', 'description': 'Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres\n\nRequirement: \\> 2.5', 'unitOfMeasure': 'Ratio of Day 0 and Day 21-28 titres', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)'}, {'type': 'PRIMARY', 'title': 'Seroconversion, A/H1N1 Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Age Group 1: Children (3-11 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.'}, {'id': 'OG001', 'title': 'Age Group 2: Adolescents (12-18 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: A single dose (0.5 ml) vaccine, administered intramuscularly.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.67', 'groupId': 'OG000'}, {'value': '66.67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21-28 days after vaccination', 'description': 'Proportion of subjects seroconverted or had a significant increase in titres\n\nRequirement: \\> 40 %', 'unitOfMeasure': 'percentage of subjects seroconverted', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)'}, {'type': 'PRIMARY', 'title': 'Seroconversion, A/H3N2 Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Age Group 1: Children (3-11 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.'}, {'id': 'OG001', 'title': 'Age Group 2: Adolescents (12-18 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: A single dose (0.5 ml) vaccine, administered intramuscularly.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.33', 'groupId': 'OG000'}, {'value': '61.67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21-28 days after vaccination', 'description': 'Proportion of subjects seroconverted or had a significant increase in titres\n\nRequirement: \\> 40 %', 'unitOfMeasure': 'percentage of subjects seroconverted', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)'}, {'type': 'PRIMARY', 'title': 'Seroconversion, B Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Age Group 1: Children (3-11 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.'}, {'id': 'OG001', 'title': 'Age Group 2: Adolescents (12-18 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: A single dose (0.5 ml) vaccine, administered intramuscularly.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.67', 'groupId': 'OG000'}, {'value': '70.00', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21-28 days after vaccination', 'description': 'Proportion of subjects seroconverted or had a significant increase in titres\n\nRequirement: \\> 40 %', 'unitOfMeasure': 'percentage of subjects seroconverted', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)'}, {'type': 'PRIMARY', 'title': 'Seroprotection, A/H1N1 Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Age Group 1: Children (3-11 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.'}, {'id': 'OG001', 'title': 'Age Group 2: Adolescents (12-18 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: A single dose (0.5 ml) vaccine, administered intramuscularly.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.67', 'groupId': 'OG000'}, {'value': '96.67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21-28 days after vaccination', 'description': 'Proportion of subjects seroprotected\n\nRequirement: \\> 70 %', 'unitOfMeasure': 'percentage of subjects seroprotected', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)'}, {'type': 'PRIMARY', 'title': 'Seroprotection, A/H3N2 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'populationDescription': 'PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)'}, {'type': 'PRIMARY', 'title': 'Seroprotection, B Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Age Group 1: Children (3-11 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.'}, {'id': 'OG001', 'title': 'Age Group 2: Adolescents (12-18 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: A single dose (0.5 ml) vaccine, administered intramuscularly.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.00', 'groupId': 'OG000'}, {'value': '86.67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21-28 days after vaccination', 'description': 'Proportion of subjects seroprotected\n\nRequirement: \\> 70 %', 'unitOfMeasure': 'percentage of subjects seroprotected', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population (subjects whose antihaemagglutination inhibition titres are available both Day 0 and Day 21-28 visits)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Age Group 1: Children (3-11 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo\n\nDosage: half of the single dose'}, {'id': 'FG001', 'title': 'Age Group 2: Adolescents', 'description': 'Intervention: Vaccination with Fluval AB Novo\n\nDosage: single dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Age Group 1: Children (3-11 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.'}, {'id': 'BG001', 'title': 'Age Group 2: Adolescents (12-18 Years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: A single dose (0.5 ml) vaccine, administered intramuscularly.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.93', 'spread': '2.65', 'groupId': 'BG000'}, {'value': '14.38', 'spread': '1.54', 'groupId': 'BG001'}, {'value': '11.16', 'spread': '3.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'description': 'Age at the time of enrolment', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hungary', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'parallel-group study in two paediatric age groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2014-10-16', 'resultsFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2015-03-06', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-17', 'studyFirstPostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in Geometric Mean Titre Ratio, A/H1N1 Strain', 'timeFrame': '21-28 days after vaccination', 'description': 'Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres\n\nRequirement: \\> 2.5'}, {'measure': 'Increase in Geometric Mean Titre Ratio, A/H3N2 Strain', 'timeFrame': '21-28 days after vaccination', 'description': 'Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres\n\nRequirement: \\> 2.5'}, {'measure': 'Increase in Geometric Mean Titre Ratio, B Strain', 'timeFrame': '21-28 days after vaccination', 'description': 'Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres\n\nRequirement: \\> 2.5'}, {'measure': 'Seroconversion, A/H1N1 Strain', 'timeFrame': '21-28 days after vaccination', 'description': 'Proportion of subjects seroconverted or had a significant increase in titres\n\nRequirement: \\> 40 %'}, {'measure': 'Seroconversion, A/H3N2 Strain', 'timeFrame': '21-28 days after vaccination', 'description': 'Proportion of subjects seroconverted or had a significant increase in titres\n\nRequirement: \\> 40 %'}, {'measure': 'Seroconversion, B Strain', 'timeFrame': '21-28 days after vaccination', 'description': 'Proportion of subjects seroconverted or had a significant increase in titres\n\nRequirement: \\> 40 %'}, {'measure': 'Seroprotection, A/H1N1 Strain', 'timeFrame': '21-28 days after vaccination', 'description': 'Proportion of subjects seroprotected\n\nRequirement: \\> 70 %'}, {'measure': 'Seroprotection, A/H3N2 Strain', 'timeFrame': '21-28 days after vaccination', 'description': 'Proportion of subjects seroprotected\n\nRequirement: \\> 70 %'}, {'measure': 'Seroprotection, B Strain', 'timeFrame': '21-28 days after vaccination', 'description': 'Proportion of subjects seroprotected\n\nRequirement: \\> 70 %'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['immunogenicity', 'reduced dose', 'Phase III', 'tolerability', 'safety'], 'conditions': ['Human Influenza']}, 'descriptionModule': {'briefSummary': 'Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/strain/0.5 ml) for Children and Adolescents.', 'detailedDescription': 'STUDY PERIOD:\n\nLength of enrollment: 2 weeks (estimated) Participation per subject: max. 1 month\n\nOBJECTIVES:\n\nImmunogenicity Objectives:\n\nTo assess immunogenicity of a single intramuscular injection of Fluval AB Novo suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/0.5 ml of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test.\n\nSafety and Tolerability Objectives:\n\nTo evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB Novo suspension for injection.\n\nCLINICAL PHASE:\n\nPhase III\n\nTYPE:\n\nInterventional, prevention\n\nDESIGN:\n\nNon-controlled, open, multi-centre\n\nMETHODS:\n\nIn this uncontrolled, open, multi-centre immunogenicity and tolerability study subjects were enrolled into two groups according to age:\n\nAge group 1: children (3-11 years): single intramuscular injection of Fluval AB Novo 0.25 ml suspension for injection; Age group 2: adolescents (12-18 years): single intramuscular injection of Fluval AB Novo 0.5 ml suspension for injection; Subjects were observed for 30 minutes after the injection for any immediate reactions.\n\nAll adolescent subjects aged 12 to 18 years and the legitimate representatives of all volunteers were requested to complete a Diary Card (DC) to record local reactions (injection site pain, erythema, swelling, induration, numbness, sensitivity and haematoma) and systemic reactions (fever, shivering, headache, malaise, fatigue, sweating, nausea, myalgia, arthralgia, dizziness and urticaria) starting on the day of vaccination on Visit 1 (Day 0) until 7 days following that.\n\nAll adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28); Serum samples for immunogenicity assays were collected immediately before immunization on Visit 1 (Day 0) and on Visit 2 (between Day 21 and Day 28) in all subjects. Immunogenicity were evaluated by HI test.\n\nINVESTIGATIONAL MEDICINAL PRODUCT:\n\nFluval AB Novo suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/0.5 ml of seasonal A/H1N1, A/H3N2 and B influenza antigens each) with aluminium phosphate gel adjuvant.\n\nLot No.: FL-N-05/13\n\nCONCOMITANT VACCINES:\n\nNo concomitant vaccination is permitted for the duration of the study except for post-exposure vaccination in a medical emergency (e.g. tetanus, rabies, hepatitis).\n\nSTUDY POPULATION:\n\nConsidering approximately 17% of drop-out (one participant out of six), in total 120 subjects (60 subjects in each age group) were enrolled in order to achieve at least 100 evaluable subjects (50 subjects in each age group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children aged 3 to 11 years, adolescents aged 12 to 18 years from both sexes;\n* Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study;\n* Female volunteers of childbearing potential with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and not become pregnant for the duration of the study;\n* Capability of adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers to understand and comply with planned study procedures;\n* Adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers provide written Informed Consent (IC) prior to initiation of study procedures;\n* Absence of existence of any exclusion criteria.\n\nExclusion Criteria:\n\n* Pregnancy, breast feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study.\n* Known hypersensitivity to eggs, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin, vancomycin or any other component of the vaccine;\n* History of Guillain-Barré syndrome;\n* History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;\n* Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure;\n* Immunosuppressive therapy within 36 months prior to vaccination;\n* Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;\n* Receipt of immunostimulants,\n* Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within 3 months prior to vaccination;\n* Suspected or known HIV, HBV or HCV infection;\n* Acute disease and/or axillary temperature ≥37oC within 3 days prior to vaccination;\n* Vaccine therapy within 4 weeks prior to vaccination;\n* Influenza vaccination (any kind) within 6 months prior to vaccination;\n* Experimental drug therapy within 4 weeks prior to vaccination;\n* Concomitant participation in another clinical study;\n* Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study;\n* Past or current psychiatric disease of the volunteer or the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the volunteer;\n* Alcohol or drug abuse of the participant or the legitimate representative."}, 'identificationModule': {'nctId': 'NCT02387294', 'briefTitle': 'Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection for Children and Adolescents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fluart Innovative Vaccine Ltd, Hungary'}, 'officialTitle': 'Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (Trivalent, Seasonal Influenza Vaccine, Active Ingredient Content: 6 μg HA/Strain/0.5 ml) for Children and Adolescents', 'orgStudyIdInfo': {'id': 'FABNovo-H-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Age group 1: children (3-11 years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.', 'interventionNames': ['Biological: Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml)']}, {'type': 'EXPERIMENTAL', 'label': 'Age group 2: adolescents (12-18 years)', 'description': 'Intervention: Vaccination with Fluval AB Novo suspension for injection.\n\nDosage: A single dose (0.5 ml) vaccine, administered intramuscularly.', 'interventionNames': ['Biological: Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml)']}], 'interventions': [{'name': 'Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml)', 'type': 'BIOLOGICAL', 'otherNames': ['Fluval AB Novo suspension for injection'], 'description': 'vaccination', 'armGroupLabels': ['Age group 1: children (3-11 years)']}, {'name': 'Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml)', 'type': 'BIOLOGICAL', 'description': 'vaccination', 'armGroupLabels': ['Age group 2: adolescents (12-18 years)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fluart Innovative Vaccine Ltd, Hungary', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}