Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-26 @ 4:25 PM
Study NCT ID:
NCT06029933
Status:
RECRUITING
Last Update Posted:
2023-09-08
First Post:
2023-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ≥65 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}], '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'}, {'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C478243', 'term': 'fluad vaccine'}, {'id': 'D007252', 'term': 'Influenza Vaccines'}, {'id': 'C000618615', 'term': 'Fluzone High-Dose'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 960000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-01', 'studyFirstSubmitDate': '2023-08-28', 'studyFirstSubmitQcDate': '2023-09-01', 'lastUpdatePostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospitalization for cardiovascular events', 'timeFrame': '≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025)', 'description': 'KPNC members ≥65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for hospitalization for cardiovascular events. This outcome will be assessed in single-season analyses (2023/24 and 2024/25 separately) and a pooled 2-seasons analysis (2023/24 and 2024/25 combined).'}, {'measure': 'PCR-confirmed influenza in subgroups with comorbidities', 'timeFrame': '≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025)', 'description': 'KPNC members ≥65 years with comorbidities (e.g., cardiovascular and respiratory conditions, diabetes, obesity) who receive Fluad or Fluzone High-Dose will be retrospectively assessed for hospitalization for PCR-confirmed influenza. This outcome will be assessed in a pooled 2-seasons analysis (2023/24 and 2024/25 combined).'}], 'primaryOutcomes': [{'measure': 'PCR-confirmed influenza', 'timeFrame': '≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025)', 'description': 'KPNC members ≥65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for the presence of PCR-confirmed influenza. This outcome will be assessed in single-season analyses (2023/24 and 2024/25 separately) and a pooled 2-seasons analysis (2023/24 and 2024/25 combined).'}], 'secondaryOutcomes': [{'measure': 'Emergency department visit or hospitalization for PCR-confirmed influenza', 'timeFrame': '≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025)', 'description': 'KPNC members ≥65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for an emergency department visit or hospitalization for PCR-confirmed influenza. This outcome will be assessed in single-season analyses (2023/24 and 2024/25 separately) and a pooled 2-seasons analysis (2023/24 and 2024/25 combined).'}, {'measure': 'Hospitalization for PCR-confirmed influenza', 'timeFrame': '≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025)', 'description': 'KPNC members ≥65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for hospitalization for PCR-confirmed influenza. This outcome will be assessed in a pooled 2-seasons analysis (2023/24 and 2024/25 combined).'}, {'measure': 'Hospitalization for all-cause community-acquired pneumonia', 'timeFrame': '≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025)', 'description': 'KPNC members ≥65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for hospitalization for all-cause community-acquired pneumonia. This outcome will be assessed in single-season analyses (2023/24 and 2024/25 separately) and a pooled 2-seasons analysis (2023/24 and 2024/25 combined).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza', 'Community-acquired Pneumonia', 'Cardiovascular Events']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the relative vaccine effectiveness of quadrivalent adjuvanted inactivated influenza vaccine (aIIV4) versus quadrivalent high-dose inactivated influenza vaccine (HD-IIV4) in preventing polymerase chain reaction (PCR)-confirmed influenza and influenza-related outcomes in adults ≥65 years of age during the 2023/24 and 2024/25 influenza seasons. The study is an observational study conducted at Kaiser Permanente Northern California (KPNC), an integrated health care system in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study includes KPNC adults ≥65 years who receive Fluad or Fluzone High-Dose influenza vaccine as part of routine clinical care during the 2023/24 and/or 2024/25 influenza seasons.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥65 years at the time of influenza vaccination\n* KPNC member at the time of vaccination\n* Receive either aIIV4 or HD-IIV4 at a KPNC facility during the 2023/24 and/or 2024/25 influenza seasons\n\nExclusion Criteria:\n\n* Age \\<65 years at the time of influenza vaccination\n* Received either aIIV4 or HD-IIV4 in the inpatient setting\n* Receive more than one influenza vaccination during a single season period (i.e., 2023/24 or 2024/25 influenza seasons)\n* Receive an influenza vaccination outside of KPNC'}, 'identificationModule': {'nctId': 'NCT06029933', 'briefTitle': 'Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ≥65 Years', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Relative Vaccine Effectiveness of Adjuvanted Quadrivalent Inactivated Influenza Vaccine vs High-Dose Quadrivalent Inactivated Influenza Vaccine Among Adults ≥65 Years for the 2023-24 and 2024-25 Seasons', 'orgStudyIdInfo': {'id': '2033496'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fluad Recipients', 'description': 'Kaiser Permanente Northern California members aged ≥65 years who receive Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)', 'interventionNames': ['Biological: Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)']}, {'label': 'Fluzone High-Dose Recipients', 'description': 'Kaiser Permanente Northern California members aged ≥65 years who receive High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)', 'interventionNames': ['Biological: High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)']}], 'interventions': [{'name': 'Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)', 'type': 'BIOLOGICAL', 'otherNames': ['Fluad'], 'description': 'Fluad Quadrivalent vaccine is an inactivated influenza vaccine formulated to contain 60 mcg of hemagglutinin (HA) total, with 15 mcg from each of the four recommended influenza strains and the MF59 adjuvant in single-dose prefilled 0.5 mL syringes. Kaiser Permanente Northern California members ≥65 years may receive Fluad as part of routine clinical care during the influenza season.', 'armGroupLabels': ['Fluad Recipients']}, {'name': 'High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)', 'type': 'BIOLOGICAL', 'otherNames': ['Fluzone High-Dose'], 'description': 'Fluzone High-Dose Quadrivalent vaccine is an inactivated split virion influenza vaccine formulated to contain 240 mcg of HA total, with 60 mcg from each of the four recommended influenza strains in single-dose prefilled 0.7 mL syringes. Kaiser Permanente Northern California members ≥65 years may receive Fluzone High-Dose as part of routine clinical care during the influenza season.', 'armGroupLabels': ['Fluzone High-Dose Recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94612', 'city': 'Oakland', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amber H. Hyman, PhD, MPH', 'role': 'CONTACT', 'email': 'Amber.Hyman@kp.org', 'phone': '510-267-7517'}, {'name': 'Nicola P. Klein, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente Northern California (entire region)', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'centralContacts': [{'name': 'Amber H. Hyman, PhD, MPH', 'role': 'CONTACT', 'email': 'Amber.Hyman@kp.org', 'phone': '510-267-7571'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seqirus', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}