Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-18 @ 3:57 AM
Study NCT ID:
NCT05648357
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2022-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Safety and Immune Response of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India
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': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited AEs were collected during a 7-day period after vaccine administration (from Day 1 to Day 7). Unsolicited AEs and SAEs were collected during a 21-day period after vaccine administration (from Day 1 to Day 21).', 'eventGroups': [{'id': 'EG000', 'title': 'Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group', 'description': 'Participants received 1 dose of seasonal FLU vaccine at Day 1.', 'otherNumAtRisk': 250, 'deathsNumAtRisk': 250, 'otherNumAffected': 70, 'seriousNumAtRisk': 250, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Administration site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v27.0'}, {'term': 'Administration site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 37, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v27.0'}, {'term': 'Administration site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v27.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v27.0'}, {'term': 'Pustule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v27.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v27.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'v27.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting Any Solicited Administration Site Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group', 'description': 'Participants received 1 dose of seasonal FLU vaccine at Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 7', 'description': 'The solicited administration site adverse events included pain, redness and swelling.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Solicited Safety Set (SSS), which included participants that received study intervention and had solicited safety data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Any Solicited Systemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group', 'description': 'Participants received 1 dose of seasonal FLU vaccine at Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 7', 'description': 'The solicited systemic events included fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), sweating and shivering.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SSS population'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group', 'description': 'Participants received 1 dose of seasonal FLU vaccine at Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 21', 'description': 'An unsolicited AE is defined as an event reported in addition to the solicited AEs during the clinical study. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Exposed Set (ES) population, which included all participants that received the study intervention.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group', 'description': 'Participants received 1 dose of seasonal FLU vaccine at Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 21', 'description': 'A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ES population'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group', 'description': 'Participants received 1 dose of seasonal FLU vaccine at Day 1.'}], 'classes': [{'title': 'A/Victoria/4897/2022 (H1N1), Day 1', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '12.4'}]}]}, {'title': 'A/Victoria/4897/2022 (H1N1), Day 22', 'categories': [{'measurements': [{'value': '187.9', 'groupId': 'OG000', 'lowerLimit': '150.2', 'upperLimit': '235.1'}]}]}, {'title': 'A/Darwin/9/2021 (H3N2), Day 1', 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '23.9'}]}]}, {'title': 'A/Darwin/9/2021 (H3N2), Day 22', 'categories': [{'measurements': [{'value': '205.3', 'groupId': 'OG000', 'lowerLimit': '169.5', 'upperLimit': '248.8'}]}]}, {'title': 'B/Austria/1359417/2021, Day 1', 'categories': [{'measurements': [{'value': '100.8', 'groupId': 'OG000', 'lowerLimit': '87.8', 'upperLimit': '115.9'}]}]}, {'title': 'B/Austria/1359417/2021, Day 22', 'categories': [{'measurements': [{'value': '903.6', 'groupId': 'OG000', 'lowerLimit': '780.4', 'upperLimit': '1046.3'}]}]}, {'title': 'B/Phuket/3073/2013, Day 1', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '82.0', 'upperLimit': '106.2'}]}]}, {'title': 'B/Phuket/3073/2013, Day 22', 'categories': [{'measurements': [{'value': '701.6', 'groupId': 'OG000', 'lowerLimit': '611.7', 'upperLimit': '804.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Baseline (Day 1) and Day 22', 'description': 'Serum HI antibodies against the four-influenza vaccine strains are expressed as GMTs, in titers. The assessed strains are: A/Victoria/4897/2022 (H1N1), A/Darwin/9/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Per Protocol Set (PPS), which included all participants who received the trial intervention as per protocol, had immunogenicity results pre- and post-dose, complied with the allowed dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.'}, {'type': 'SECONDARY', 'title': 'Mean Geometric Increase (MGI) of Serum HI Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group', 'description': 'Participants received 1 dose of seasonal FLU vaccine at Day 1.'}], 'classes': [{'title': 'A/Victoria/4897/2022 (H1N1)', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '13.6', 'upperLimit': '22.9'}]}]}, {'title': 'A/Darwin/9/2021 (H3N2)', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '12.7'}]}]}, {'title': 'B/Austria/1359417/2021', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '10.7'}]}]}, {'title': 'B/Phuket/3073/2013', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '8.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 22 (compared with Baseline [Day 1])', 'description': 'MGI is defined as the fold increase in post-vaccination serum HI GMTs compared with Baseline. Analysis was performed for four influenza strains: A/Victoria/4897/2022 (H1N1), A/Darwin/9/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013.', 'unitOfMeasure': 'Fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Seroconversion Rate (SCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group', 'description': 'Participants received 1 dose of seasonal FLU vaccine at Day 1.'}], 'classes': [{'title': 'A/Victoria/4897/2022 (H1N1)', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}]}]}, {'title': 'A/Darwin/9/2021 (H3N2)', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}]}]}, {'title': 'B/Austria/1359417/2021', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}]}]}, {'title': 'B/Phuket/3073/2013', 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 22', 'description': 'SCR is defined as the percentage of participants who have either a pre-vaccination titer less than (\\<) 1:10 and a postvaccination titer greater than or equal to (\\>=) 1:40 or a pre-vaccination titer \\>= 1:10 and at least a 4-fold increase in post-vaccination titer.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Seroprotection Rate (SPR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group', 'description': 'Participants received 1 dose of seasonal FLU vaccine at Day 1.'}], 'classes': [{'title': 'A/Victoria/4897/2022 (H1N1), Day 1', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'A/Victoria/4897/2022 (H1N1), Day 22', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}]}]}, {'title': 'A/Darwin/9/2021 (H3N2), Day 1', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'A/Darwin/9/2021 (H3N2), Day 22', 'categories': [{'measurements': [{'value': '187', 'groupId': 'OG000'}]}]}, {'title': 'B/Austria/1359417/2021, Day 1', 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}]}]}, {'title': 'B/Austria/1359417/2021, Day 22', 'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000'}]}]}, {'title': 'B/Phuket/3073/2013, Day 1', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}]}]}, {'title': 'B/Phuket/3073/2013, Day 22', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 1 and Day 22', 'description': 'SPR is defined as the percentage of participants with a serum HI titer \\>=1:40.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group', 'description': 'Participants received 1 dose of seasonal FLU vaccine at Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '247'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'CONSENT WITHDRAWAL, NOT DUE TO AN AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group', 'description': 'Participants received 1 dose of seasonal FLU vaccine at Day 1.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.8', 'spread': '5.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'YEARS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '104', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '146', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian - Central / South Asian Heritage', 'categories': [{'measurements': [{'value': '250', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-05', 'size': 1794982, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-14T01:54', 'hasProtocol': True}, {'date': '2023-11-17', 'size': 1272044, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-14T01:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2022-12-05', 'resultsFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2022-12-05', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-27', 'studyFirstPostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting Any Solicited Administration Site Adverse Event', 'timeFrame': 'Day 1 to Day 7', 'description': 'The solicited administration site adverse events included pain, redness and swelling.'}, {'measure': 'Number of Participants Reporting Any Solicited Systemic Events', 'timeFrame': 'Day 1 to Day 7', 'description': 'The solicited systemic events included fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), sweating and shivering.'}, {'measure': 'Number of Participants Reporting Unsolicited Adverse Events (AEs)', 'timeFrame': 'Day 1 to Day 21', 'description': 'An unsolicited AE is defined as an event reported in addition to the solicited AEs during the clinical study. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.'}, {'measure': 'Number of Participants Reporting Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 to Day 21', 'description': 'A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies', 'timeFrame': 'At Baseline (Day 1) and Day 22', 'description': 'Serum HI antibodies against the four-influenza vaccine strains are expressed as GMTs, in titers. The assessed strains are: A/Victoria/4897/2022 (H1N1), A/Darwin/9/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013.'}, {'measure': 'Mean Geometric Increase (MGI) of Serum HI Antibodies', 'timeFrame': 'At Day 22 (compared with Baseline [Day 1])', 'description': 'MGI is defined as the fold increase in post-vaccination serum HI GMTs compared with Baseline. Analysis was performed for four influenza strains: A/Victoria/4897/2022 (H1N1), A/Darwin/9/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013.'}, {'measure': 'Number of Participants With Seroconversion Rate (SCR)', 'timeFrame': 'At Day 22', 'description': 'SCR is defined as the percentage of participants who have either a pre-vaccination titer less than (\\<) 1:10 and a postvaccination titer greater than or equal to (\\>=) 1:40 or a pre-vaccination titer \\>= 1:10 and at least a 4-fold increase in post-vaccination titer.'}, {'measure': 'Number of Participants With Seroprotection Rate (SPR)', 'timeFrame': 'At Day 1 and Day 22', 'description': 'SPR is defined as the percentage of participants with a serum HI titer \\>=1:40.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza, Human']}, 'referencesModule': {'references': [{'pmid': '41159757', 'type': 'DERIVED', 'citation': 'Jain V, Cauwberghs F, Qian H, Best-Sule K, Gupta V, Tatchou EN, Struyf F. Reactogenicity, safety, and immunogenicity of a quadrivalent seasonal influenza vaccine in adults aged 65 years and older: Phase 4 study results from India during December 2023-February 2024. Hum Vaccin Immunother. 2025 Dec;21(1):2578084. doi: 10.1080/21645515.2025.2578084. Epub 2025 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of Fluarix Tetra (0.5 milliliter \\[mL\\]) (Northern Hemisphere (NH)2023-2024) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the Indian regulatory authorities (CDSCO) for this age group in India.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female participants aged \\>= 65 years of age\n* Participants and/or legally acceptable representative (s) (LAR) who in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits\n* Written or witnessed/thumb printed informed consent obtained from the participant and/or participant's LAR(s) after the study has been explained according to the local authority requirements and prior to performance of any study-specific procedure\n\nExclusion Criteria:\n\n* History of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine.\n* Receipt of licensed vaccine, immune sera and/or any blood products, or an investigational trial agent within previous 30 days or planned during their participation in the trial.\n* Receipt of any flu vaccine within 6 months before trial start or any other vaccine within 30 days before the trial.\n* Receipt of any dose of a Coronavirus Disease 2019 (COVID-19) vaccine within 15 days of trial start.\n* History of Guillain-Barré Syndrome.\n* Altered immune status or chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within six months prior to administration of trial vaccine.\n* History of acute infectious disease or acute respiratory illness needing antibiotics or antivirals in the previous 7 days, based on investigator's judgement.\n* If a participant candidate has fever, the trial vaccination should be postponed to when the fever has resolved for at least 2 days (temporary exclusion criterion). Fever is defined as temperature \\>=38.0 degree Celsius (°C) (100.4 degrees Fahrenheit \\[°F\\]) by any route. The preferred location for measuring temperature will be oral route.\n* Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination, or laboratory screening tests.\n* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the trial."}, 'identificationModule': {'nctId': 'NCT05648357', 'briefTitle': 'A Study to Assess the Safety and Immune Response of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Single-arm, Open-label, Multi-center, Phase IV Trial to Evaluate the Reactogenicity, Safety, and Immunogenicity of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India', 'orgStudyIdInfo': {'id': '218702'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quadrivalent seasonal influenza (FLU D-QIV) vaccine group', 'description': 'Participants received 1 dose of seasonal FLU vaccine at Day 1.', 'interventionNames': ['Biological: Fluarix Tetra Vaccine']}], 'interventions': [{'name': 'Fluarix Tetra Vaccine', 'type': 'BIOLOGICAL', 'description': 'A single dose of Fluarix Tetra vaccine administered intramuscularly (IM) on day 1.', 'armGroupLabels': ['Quadrivalent seasonal influenza (FLU D-QIV) vaccine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '590010', 'city': 'Belagavi', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 15.85212, 'lon': 74.50447}}, {'zip': '603211', 'city': 'Kattankulathur', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 12.81615, 'lon': 80.03677}}, {'zip': '422002', 'city': 'Nashik', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'zip': '422003', 'city': 'Nashik', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'zip': '221010', 'city': 'Varanasi', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.31668, 'lon': 83.01041}}, {'zip': '530002', 'city': 'Visakhapatnam', 'country': 'India', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.', 'ipdSharing': 'YES', 'description': 'IPD for this study will be made available via the Clinical Study Data Request site.', 'accessCriteria': 'Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}