Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT04537234
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2020-08-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Taiwanese Adults 65 Years of Age and Older
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': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '6#', 'organization': 'Sanofi Pasteur'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 (post-vaccination) up to 28 days post-vaccination.', 'description': 'A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to the product administered. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on SafAS.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)', 'description': 'Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 46, 'seriousNumAtRisk': 82, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)', 'description': 'Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 35, 'seriousNumAtRisk': 83, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Injection Site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'notes': 'Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 83, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)', 'description': 'Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)', 'description': 'Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '30.6'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '18.5', 'upperLimit': '31.5'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000', 'lowerLimit': '78.4', 'upperLimit': '156'}, {'value': '169', 'groupId': 'OG001', 'lowerLimit': '120', 'upperLimit': '238'}]}]}, {'title': 'B1', 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '66.7', 'upperLimit': '116'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '76.6', 'upperLimit': '126'}]}]}, {'title': 'B2', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000', 'lowerLimit': '111', 'upperLimit': '199'}, {'value': '160', 'groupId': 'OG001', 'lowerLimit': '121', 'upperLimit': '211'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination)', 'description': 'GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria Lineage), and B2 (B Yamagata Lineage). Titers were expressed in terms of 1/dilution.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the full analysis set (FAS) that included randomized participants who received one of the study vaccine and had a post-vaccination blood sample. Participants were analyzed according to the vaccine group to which they were randomized.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)', 'description': 'Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)', 'description': 'Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '283', 'groupId': 'OG000', 'lowerLimit': '221', 'upperLimit': '364'}, {'value': '109', 'groupId': 'OG001', 'lowerLimit': '78.2', 'upperLimit': '151'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '643', 'groupId': 'OG000', 'lowerLimit': '522', 'upperLimit': '791'}, {'value': '427', 'groupId': 'OG001', 'lowerLimit': '324', 'upperLimit': '563'}]}]}, {'title': 'B1', 'categories': [{'measurements': [{'value': '812', 'groupId': 'OG000', 'lowerLimit': '645', 'upperLimit': '1023'}, {'value': '324', 'groupId': 'OG001', 'lowerLimit': '253', 'upperLimit': '414'}]}]}, {'title': 'B2', 'categories': [{'measurements': [{'value': '707', 'groupId': 'OG000', 'lowerLimit': '595', 'upperLimit': '840'}, {'value': '361', 'groupId': 'OG001', 'lowerLimit': '290', 'upperLimit': '450'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 28 (post-vaccination)', 'description': 'GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on FAS.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)', 'description': 'Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)', 'description': 'Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '9.09', 'upperLimit': '15.9'}, {'value': '4.50', 'groupId': 'OG001', 'lowerLimit': '3.47', 'upperLimit': '5.82'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '5.81', 'groupId': 'OG000', 'lowerLimit': '4.28', 'upperLimit': '7.87'}, {'value': '2.53', 'groupId': 'OG001', 'lowerLimit': '1.87', 'upperLimit': '3.41'}]}]}, {'title': 'B1', 'categories': [{'measurements': [{'value': '9.23', 'groupId': 'OG000', 'lowerLimit': '7.00', 'upperLimit': '12.2'}, {'value': '3.30', 'groupId': 'OG001', 'lowerLimit': '2.48', 'upperLimit': '4.39'}]}]}, {'title': 'B2', 'categories': [{'measurements': [{'value': '4.76', 'groupId': 'OG000', 'lowerLimit': '3.65', 'upperLimit': '6.21'}, {'value': '2.26', 'groupId': 'OG001', 'lowerLimit': '1.76', 'upperLimit': '2.89'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 (pre-vaccination), Day 28 (post-vaccination)', 'description': 'GMTRs of anti-influenza antibodies were measured by using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on FAS.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)', 'description': 'Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)', 'description': 'Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '86.3', 'groupId': 'OG000', 'lowerLimit': '76.7', 'upperLimit': '92.9'}, {'value': '50.6', 'groupId': 'OG001', 'lowerLimit': '39.4', 'upperLimit': '61.8'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000', 'lowerLimit': '49.7', 'upperLimit': '71.9'}, {'value': '28.9', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '39.9'}]}]}, {'title': 'B1', 'categories': [{'measurements': [{'value': '78.8', 'groupId': 'OG000', 'lowerLimit': '68.2', 'upperLimit': '87.1'}, {'value': '37.3', 'groupId': 'OG001', 'lowerLimit': '27.0', 'upperLimit': '48.7'}]}]}, {'title': 'B2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '38.6', 'upperLimit': '61.4'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '34.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 (post-vaccination)', 'description': 'Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (\\<) 10 (1/dilution) at Day 0 and a post-vaccination titer greater than or equal to (\\>=) 40 (1/dilution) at Day 28 or a pre-vaccination titer \\>=10 (1/dilution) at Day 0 and a \\>= four-fold increase in post-vaccination titer at Day 28.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on FAS.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)', 'description': 'Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)', 'description': 'Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000', 'lowerLimit': '23.6', 'upperLimit': '45.2'}, {'value': '36.1', 'groupId': 'OG001', 'lowerLimit': '25.9', 'upperLimit': '47.4'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '76.3', 'groupId': 'OG000', 'lowerLimit': '65.4', 'upperLimit': '85.1'}, {'value': '84.3', 'groupId': 'OG001', 'lowerLimit': '74.7', 'upperLimit': '91.4'}]}]}, {'title': 'B1', 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000', 'lowerLimit': '71.0', 'upperLimit': '89.1'}, {'value': '85.5', 'groupId': 'OG001', 'lowerLimit': '76.1', 'upperLimit': '92.3'}]}]}, {'title': 'B2', 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '92.0'}, {'value': '86.7', 'groupId': 'OG001', 'lowerLimit': '77.5', 'upperLimit': '93.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (pre-vaccination)', 'description': 'Antibody titer was measured by using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on FAS.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)', 'description': 'Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)', 'description': 'Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.'}], 'classes': [{'title': 'A/H1N1', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '91.3', 'upperLimit': '99.7'}, {'value': '79.5', 'groupId': 'OG001', 'lowerLimit': '69.2', 'upperLimit': '87.6'}]}]}, {'title': 'A/H3N2', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100'}, {'value': '96.4', 'groupId': 'OG001', 'lowerLimit': '89.8', 'upperLimit': '99.2'}]}]}, {'title': 'B1', 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '93.2', 'upperLimit': '100'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '93.5', 'upperLimit': '100'}]}]}, {'title': 'B2', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 (post-vaccination)', 'description': 'Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on FAS.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)', 'description': 'Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)', 'description': 'Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 minutes post-vaccination', 'description': 'An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the safety analysis set (SafAS) that included participants who had received one of the study vaccines and had any safety data available; and were analyzed according to the vaccine they actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Solicited Injection Site and Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)', 'description': 'Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)', 'description': 'Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.'}], 'classes': [{'title': 'Injection site Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Injection site Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Injection site Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Injection site Induration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Injection site Bruising', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Malaise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Shivering', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days post-vaccination', 'description': 'A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included pain, erythema, swelling, induration, and bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on the SafAS. Here, 'Number analyzed' = participants with available data for each specified category."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unsolicited Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)', 'description': 'Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)', 'description': 'Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 28 days post-vaccination', 'description': 'An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the SafAS.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)', 'description': 'Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.'}, {'id': 'OG001', 'title': 'Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)', 'description': 'Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AESIs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to 28 days post-vaccination', 'description': 'An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the SafAS.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)', 'description': 'Participants received a single injection of 0.7 milliliters (mL) QIV-HD, intramuscularly (IM) at Day 0.'}, {'id': 'FG001', 'title': 'Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)', 'description': 'Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 4 active centers in Taiwan. A total of 165 participants were enrolled and randomized between 10 November 2020 to 12 January 2021.', 'preAssignmentDetails': 'A total of 165 participants were vaccinated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)', 'description': 'Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.'}, {'id': 'BG001', 'title': 'Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)', 'description': 'Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.5', 'spread': '5.37', 'groupId': 'BG000'}, {'value': '71.4', 'spread': '5.71', 'groupId': 'BG001'}, {'value': '71.4', 'spread': '5.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-14', 'size': 775569, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-27T09:37', 'hasProtocol': True}, {'date': '2021-04-30', 'size': 341622, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-27T09:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study was modified double-blind. The designated vaccine prepare(s)/administrator(s) would be unblinded given that the QIV-HD and QIV-SD vaccines had different dose volumes. Neither the participant nor the investigator nor the study staff in charge of vaccination was aware of which vaccine was administered (the syringes was masked to maintained the blinding of the participants and other members of the clinical site). The unblinded designated vaccine preparer(s)/administrator(s) was not involved in any of the blinded study assessments (eg, immunogenicity, safety).'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2020-08-26', 'resultsFirstSubmitDate': '2021-10-08', 'studyFirstSubmitQcDate': '2020-09-02', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2021-10-08', 'studyFirstPostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0', 'timeFrame': 'Day 0 (pre-vaccination)', 'description': 'GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria Lineage), and B2 (B Yamagata Lineage). Titers were expressed in terms of 1/dilution.'}, {'measure': 'Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28', 'timeFrame': 'Day 28 (post-vaccination)', 'description': 'GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution.'}, {'measure': 'Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies', 'timeFrame': 'Day 0 (pre-vaccination), Day 28 (post-vaccination)', 'description': 'GMTRs of anti-influenza antibodies were measured by using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).'}, {'measure': 'Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens', 'timeFrame': 'Day 28 (post-vaccination)', 'description': 'Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (\\<) 10 (1/dilution) at Day 0 and a post-vaccination titer greater than or equal to (\\>=) 40 (1/dilution) at Day 28 or a pre-vaccination titer \\>=10 (1/dilution) at Day 0 and a \\>= four-fold increase in post-vaccination titer at Day 28.'}, {'measure': 'Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0', 'timeFrame': 'Day 0 (pre-vaccination)', 'description': 'Antibody titer was measured by using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).'}, {'measure': 'Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28', 'timeFrame': 'Day 28 (post-vaccination)', 'description': 'Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).'}, {'measure': 'Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)', 'timeFrame': 'Within 30 minutes post-vaccination', 'description': 'An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.'}, {'measure': 'Number of Participants With Solicited Injection Site and Systemic Reactions', 'timeFrame': 'Within 7 days post-vaccination', 'description': 'A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included pain, erythema, swelling, induration, and bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.'}, {'measure': 'Number of Participants With Unsolicited Adverse Events', 'timeFrame': 'Within 28 days post-vaccination', 'description': 'An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)', 'timeFrame': 'From Day 0 up to 28 days post-vaccination', 'description': 'An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza'], 'conditions': ['Influenza (Healthy Volunteers)']}, 'referencesModule': {'references': [{'pmid': '36216650', 'type': 'DERIVED', 'citation': 'Chen JY, Hsieh SM, Hwang SJ, Liu CS, Li X, Fournier M, Yeh TY, Yin JK, Samson SI. Immunogenicity and safety of high-dose quadrivalent influenza vaccine in older adults in Taiwan: A phase III, randomized, multi-center study. Vaccine. 2022 Oct 26;40(45):6450-6454. doi: 10.1016/j.vaccine.2022.09.078. Epub 2022 Oct 7.'}], 'seeAlsoLinks': [{'url': 'https://www.trialsummaries.com/Study/StudyDetails?id=25342&tenant=MT_SNY_9011', 'label': 'QHD00023 Plain Language Results Summary'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nImmunogenicity: To describe the immune response induced by high-dose quadrivalent influenza vaccine (QIV-HD) and AdimFlu-S (QIS) by hemagglutinin inhibition (HAI) measurement method in all participants.\n\nSafety: To describe the safety profile of all participants in each study groups.', 'detailedDescription': "The duration of each participant's participation was approximately 28 days (Day 0 through Day 28 \\[+ 7 days\\])."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria :\n\n* 65 years and older on the day of inclusion.\n* Able to attend all scheduled visits and complied with all study procedures.\n\nExclusion criteria:\n\n* Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.\n* Receipt of any vaccine in the 4 weeks (28 days) preceding the study vaccination or planned receipt of any vaccine prior to Visit 2.\n* Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine.\n* Receipt of immune globulins, blood or blood-derived products in the past 3 months.\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).\n* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the study or to a vaccine containing any of the same substances.\n* Thrombocytopenia, bleeding disorder, or receipt of anticoagulants that based on Investigator's judgment contraindicate intramuscular vaccination.\n* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.\n* Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.\n* Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion.\n* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature greater than or equal to \\[\\>=\\] 38.0 degree Celsius). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.\n* Personal or family history of Guillain-Barré syndrome.\n* Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that was stable at the time of vaccination in the absence of therapy and participants who had a history of neoplastic disease and had been disease free for \\>=5 years).\n* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse) of the Investigator or employee with direct involvement in the proposed study.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT04537234', 'briefTitle': 'Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Taiwanese Adults 65 Years of Age and Older', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine in Subjects 65 Years of Age and Older in Taiwan', 'orgStudyIdInfo': {'id': 'QHD00023'}, 'secondaryIdInfos': [{'id': 'U1111-1238-1970', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)', 'description': 'Participants received a single injection of 0.7 milliliters (mL) QIV-HD, intramuscularly (IM) at Day 0.', 'interventionNames': ['Biological: High-Dose Quadrivalent Influenza Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)', 'description': 'Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.', 'interventionNames': ['Biological: Standard-Dose Quadrivalent Influenza Vaccine']}], 'interventions': [{'name': 'High-Dose Quadrivalent Influenza Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone® High Dose, Efluelda™'], 'description': 'Pharmaceutical form: Suspension for injection in pre-filled syringe,\n\nRoute of administration: IM', 'armGroupLabels': ['Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)']}, {'name': 'Standard-Dose Quadrivalent Influenza Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['AdimFlu-S (QIS)'], 'description': 'Pharmaceutical form: Suspension for injection in pre-filled syringe,\n\nRoute of administration: IM', 'armGroupLabels': ['Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40447', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Investigational Site Number 1580004', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Investigational Site Number 1580001', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Investigational Site Number 1580002', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Investigational Site Number 1580003', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}