Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-05-29 @ 4:22 PM
Study NCT ID:
NCT03694392
Status:
COMPLETED
Last Update Posted:
2025-04-08
First Post:
2018-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Flublok v. Standard Dose Vaccine Effectiveness Among Kaiser Permanente Northern California Adults 18-64 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D020521', 'term': 'Stroke'}], '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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Amber.Hyman@kp.org', 'phone': '510-267-7517', 'title': 'Amber Hsiao Hyman, Senior Research Project Manger', 'organization': 'Kaiser Permanente Vaccine Study Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 8 months', 'eventGroups': [{'id': 'EG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs.", 'otherNumAtRisk': 632962, 'deathsNumAtRisk': 632962, 'otherNumAffected': 0, 'seriousNumAtRisk': 632962, 'deathsNumAffected': 352, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.', 'otherNumAtRisk': 997366, 'deathsNumAtRisk': 997366, 'otherNumAffected': 0, 'seriousNumAtRisk': 997366, 'deathsNumAffected': 501, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279400', 'groupId': 'OG000'}, {'value': '395852', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '559', 'groupId': 'OG000'}, {'value': '925', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.76', 'ciUpperLimit': '0.94', 'pValueComment': "Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.", 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.3% (5.9%, 23.8%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adults 50-64 Years Old Hospitalized With PCR-confirmed Influenza', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279400', 'groupId': 'OG000'}, {'value': '395852', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.09', 'pValueComment': "Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.", 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.9% (-9.2% to 35.2%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay and had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adults 50-64 Years Old Hospitalized With Community-acquired Pneumonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279400', 'groupId': 'OG000'}, {'value': '395852', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.06', 'pValueComment': "Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.", 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 16.7% (-5.6% to 34.4%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for community-acquired pneumonia (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adults 50-64 Years Old Hospitalized With Cardio-respiratory Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279400', 'groupId': 'OG000'}, {'value': '395852', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '631', 'groupId': 'OG000'}, {'value': '890', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.08', 'pValueComment': "Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.", 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 2.4% (-8.1% to 11.9%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for cardio-respiratory events (e.g., pneumonia, other lower respiratory infections, acute myocardial infarction, congestive heart failure, stroke) (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Adults 18-49 Years Old Hospitalized With Community-acquired Pneumonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353562', 'groupId': 'OG000'}, {'value': '601514', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.80', 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -15.7% (-79.5% to 25.5%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for community-acquired pneumonia (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Adults 50-64 Years Old With Influenza-Like Illness (ILI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279400', 'groupId': 'OG000'}, {'value': '395852', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '1826', 'groupId': 'OG000'}, {'value': '2871', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.001', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.06', 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -0.1% (-6.0% to 5.4%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for influenza-like illness (ILI) International Classification of Diseases, 10th Edition (and absence of a negative lab-confirmed influenza)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Adults 50-64 Years Old With All-Cause-Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279400', 'groupId': 'OG000'}, {'value': '395852', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '4308', 'groupId': 'OG000'}, {'value': '6005', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '5.5', 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 1.8% (-2.2% to 5.5%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause hospitalizations', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Adults 50-64 Years Old With All-Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279400', 'groupId': 'OG000'}, {'value': '395852', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '286', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.4', 'ciLowerLimit': '-5.4', 'ciUpperLimit': '22.1', 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 9.4% (-5.4% to 22.1%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353562', 'groupId': 'OG000'}, {'value': '601514', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '827', 'groupId': 'OG000'}, {'value': '1510', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.02', 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 6.2% (-2.2% to 13.9%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Adults 18-49 Years Old Hospitalized With PCR-confirmed Influenza', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353562', 'groupId': 'OG000'}, {'value': '601514', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.52', 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -6.9% (-51.6% to 24.6%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay and had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Adults 18-49 Years Old Hospitalized With Cardio-respiratory Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353562', 'groupId': 'OG000'}, {'value': '601514', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.12', 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 5.2% (-18.8% to 24.4%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for cardio-respiratory events (e.g., pneumonia, other lower respiratory infections, acute myocardial infarction, congestive heart failure, stroke) (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Adults 18-49 Years Old With Influenza-Like Illness (ILI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353562', 'groupId': 'OG000'}, {'value': '601514', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '2904', 'groupId': 'OG000'}, {'value': '5434', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.85', 'ciUpperLimit': '0.93', 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.8% (6.6% to 14.7%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for influenza-like illness (ILI) International Classification of Diseases, 10th Edition (and absence of a negative lab-confirmed influenza)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Adults 18-49 Years Old With All-Cause-Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353562', 'groupId': 'OG000'}, {'value': '601514', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '1858', 'groupId': 'OG000'}, {'value': '2950', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.001', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.06', 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -0.1% (-6.2% to 5.6%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause hospitalizations', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Adults 18-49 Years Old With All-Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353562', 'groupId': 'OG000'}, {'value': '601514', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.46', 'ciLowerLimit': '1.06', 'ciUpperLimit': '2.00', 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -45.5% (-100.2% to -5.8%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353562', 'groupId': 'OG000'}, {'value': '601514', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '682', 'groupId': 'OG000'}, {'value': '1282', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.82', 'ciUpperLimit': '0.99', 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.2% (1.4% to 18.2%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza A test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353562', 'groupId': 'OG000'}, {'value': '601514', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.43', 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -16.2% (-43.0% to 5.5%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza B test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279400', 'groupId': 'OG000'}, {'value': '395852', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '522', 'groupId': 'OG000'}, {'value': '862', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.76', 'ciUpperLimit': '0.94', 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.7% (6.0% to 24.5%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza A test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279400', 'groupId': 'OG000'}, {'value': '395852', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'OG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.34', 'estimateComment': 'Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.3% (-33.9% to 39.9%)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza B test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'FG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1018043'}, {'groupId': 'FG001', 'numSubjects': '1758235'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '"Completed" refers to final analysis study population (as opposed to reflecting drop-out, etc.). All individuals included at the start were vaccinated as part of routine clinical care.\n\n"Not Completed" refers to vaccinated individuals who were not included in the final analysis due to not being part of the randomization process or other reasons.', 'groupId': 'FG000', 'numSubjects': '632962'}, {'comment': '"Completed" refers to final analysis study population (as opposed to reflecting drop-out, etc.). All individuals included at the start were vaccinated as part of routine clinical care.\n\n"Not Completed" refers to vaccinated individuals who were not included in the final analysis due to not being part of the randomization process or other reasons.', 'groupId': 'FG001', 'numSubjects': '997366'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '385081'}, {'groupId': 'FG001', 'numSubjects': '760869'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '632962', 'groupId': 'BG000'}, {'value': '997366', 'groupId': 'BG001'}, {'value': '1630328', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Flublok Recipients', 'description': "Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.\n\nFlublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs."}, {'id': 'BG001', 'title': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).\n\nStandard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '632962', 'groupId': 'BG000'}, {'value': '997366', 'groupId': 'BG001'}, {'value': '1630328', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '363921', 'groupId': 'BG000'}, {'value': '585482', 'groupId': 'BG001'}, {'value': '949403', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '269041', 'groupId': 'BG000'}, {'value': '411884', 'groupId': 'BG001'}, {'value': '680925', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '275117', 'groupId': 'BG000'}, {'value': '420570', 'groupId': 'BG001'}, {'value': '695687', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '27601', 'groupId': 'BG000'}, {'value': '45674', 'groupId': 'BG001'}, {'value': '73275', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '159104', 'groupId': 'BG000'}, {'value': '255008', 'groupId': 'BG001'}, {'value': '414112', 'groupId': 'BG002'}]}]}, {'title': 'Pacific Islander', 'categories': [{'measurements': [{'value': '4824', 'groupId': 'BG000'}, {'value': '7499', 'groupId': 'BG001'}, {'value': '12323', 'groupId': 'BG002'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '2908', 'groupId': 'BG000'}, {'value': '4635', 'groupId': 'BG001'}, {'value': '7543', 'groupId': 'BG002'}]}]}, {'title': 'Multiracial', 'categories': [{'measurements': [{'value': '16229', 'groupId': 'BG000'}, {'value': '25946', 'groupId': 'BG001'}, {'value': '42175', 'groupId': 'BG002'}]}]}, {'title': 'Unknown/Other', 'categories': [{'measurements': [{'value': '147179', 'groupId': 'BG000'}, {'value': '238034', 'groupId': 'BG001'}, {'value': '385213', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '632962', 'groupId': 'BG000'}, {'value': '997366', 'groupId': 'BG001'}, {'value': '1630328', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of asthma', 'classes': [{'categories': [{'measurements': [{'value': '86127', 'groupId': 'BG000'}, {'value': '132550', 'groupId': 'BG001'}, {'value': '218677', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of diabetes', 'classes': [{'categories': [{'measurements': [{'value': '67026', 'groupId': 'BG000'}, {'value': '97192', 'groupId': 'BG001'}, {'value': '164218', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of chronic obstructive pulmonary disease', 'classes': [{'categories': [{'measurements': [{'value': '6174', 'groupId': 'BG000'}, {'value': '8563', 'groupId': 'BG001'}, {'value': '14737', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of coronary heart disease', 'classes': [{'categories': [{'measurements': [{'value': '11947', 'groupId': 'BG000'}, {'value': '16902', 'groupId': 'BG001'}, {'value': '28849', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Receipt of influenza vaccine in previous year', 'classes': [{'categories': [{'measurements': [{'value': '414500', 'groupId': 'BG000'}, {'value': '640263', 'groupId': 'BG001'}, {'value': '1054763', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Charlson Comorbidity Index', 'classes': [{'title': 'No Charlson comorbidities', 'categories': [{'measurements': [{'value': '508118', 'groupId': 'BG000'}, {'value': '812879', 'groupId': 'BG001'}, {'value': '1320997', 'groupId': 'BG002'}]}]}, {'title': 'CCI=1', 'categories': [{'measurements': [{'value': '81980', 'groupId': 'BG000'}, {'value': '122562', 'groupId': 'BG001'}, {'value': '204542', 'groupId': 'BG002'}]}]}, {'title': 'CCI≥2', 'categories': [{'measurements': [{'value': '42864', 'groupId': 'BG000'}, {'value': '61925', 'groupId': 'BG001'}, {'value': '104789', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index', 'classes': [{'title': '0 - < 18.5 kg/m²', 'categories': [{'measurements': [{'value': '7819', 'groupId': 'BG000'}, {'value': '12311', 'groupId': 'BG001'}, {'value': '20130', 'groupId': 'BG002'}]}]}, {'title': '18.5 - < 25 kg/m²', 'categories': [{'measurements': [{'value': '188431', 'groupId': 'BG000'}, {'value': '306194', 'groupId': 'BG001'}, {'value': '494625', 'groupId': 'BG002'}]}]}, {'title': '25 - < 30 kg/m²', 'categories': [{'measurements': [{'value': '206663', 'groupId': 'BG000'}, {'value': '323624', 'groupId': 'BG001'}, {'value': '530287', 'groupId': 'BG002'}]}]}, {'title': '≥ 30 kg/m²', 'categories': [{'measurements': [{'value': '209817', 'groupId': 'BG000'}, {'value': '321607', 'groupId': 'BG001'}, {'value': '531424', 'groupId': 'BG002'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '20232', 'groupId': 'BG000'}, {'value': '33630', 'groupId': 'BG001'}, {'value': '53862', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of weeks with outpatient visits in prior year', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '57602', 'groupId': 'BG000'}, {'value': '92349', 'groupId': 'BG001'}, {'value': '149951', 'groupId': 'BG002'}]}]}, {'title': '1-3', 'categories': [{'measurements': [{'value': '270701', 'groupId': 'BG000'}, {'value': '427043', 'groupId': 'BG001'}, {'value': '697744', 'groupId': 'BG002'}]}]}, {'title': '4-7', 'categories': [{'measurements': [{'value': '165444', 'groupId': 'BG000'}, {'value': '256965', 'groupId': 'BG001'}, {'value': '422409', 'groupId': 'BG002'}]}]}, {'title': '≥8', 'categories': [{'measurements': [{'value': '139215', 'groupId': 'BG000'}, {'value': '221009', 'groupId': 'BG001'}, {'value': '360224', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of inpatient stays in prior year', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '573712', 'groupId': 'BG000'}, {'value': '902365', 'groupId': 'BG001'}, {'value': '1476077', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '44860', 'groupId': 'BG000'}, {'value': '71208', 'groupId': 'BG001'}, {'value': '116068', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '9707', 'groupId': 'BG000'}, {'value': '15896', 'groupId': 'BG001'}, {'value': '25603', 'groupId': 'BG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '2885', 'groupId': 'BG000'}, {'value': '4735', 'groupId': 'BG001'}, {'value': '7620', 'groupId': 'BG002'}]}]}, {'title': '≥4', 'categories': [{'measurements': [{'value': '1798', 'groupId': 'BG000'}, {'value': '3162', 'groupId': 'BG001'}, {'value': '4960', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior membership', 'classes': [{'title': '<1 year', 'categories': [{'measurements': [{'value': '78004', 'groupId': 'BG000'}, {'value': '127160', 'groupId': 'BG001'}, {'value': '205164', 'groupId': 'BG002'}]}]}, {'title': '1 to <2 years', 'categories': [{'measurements': [{'value': '62407', 'groupId': 'BG000'}, {'value': '100315', 'groupId': 'BG001'}, {'value': '162722', 'groupId': 'BG002'}]}]}, {'title': '2 to <3 years', 'categories': [{'measurements': [{'value': '52678', 'groupId': 'BG000'}, {'value': '84938', 'groupId': 'BG001'}, {'value': '137616', 'groupId': 'BG002'}]}]}, {'title': '3 to <4 years', 'categories': [{'measurements': [{'value': '45919', 'groupId': 'BG000'}, {'value': '74028', 'groupId': 'BG001'}, {'value': '119947', 'groupId': 'BG002'}]}]}, {'title': '4 to <5 years', 'categories': [{'measurements': [{'value': '41545', 'groupId': 'BG000'}, {'value': '66292', 'groupId': 'BG001'}, {'value': '107837', 'groupId': 'BG002'}]}]}, {'title': '≥5 years', 'categories': [{'measurements': [{'value': '352409', 'groupId': 'BG000'}, {'value': '544633', 'groupId': 'BG001'}, {'value': '897042', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Final analysis population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-08', 'size': 721525, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-25T01:27', 'hasProtocol': True}, {'date': '2020-06-16', 'size': 478467, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-25T01:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2776278}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2018-09-27', 'resultsFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2018-10-01', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-20', 'studyFirstPostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Adults 18-49 Years Old Hospitalized With Community-acquired Pneumonia', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for community-acquired pneumonia (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).'}, {'measure': 'Number of Adults 50-64 Years Old With Influenza-Like Illness (ILI)', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for influenza-like illness (ILI) International Classification of Diseases, 10th Edition (and absence of a negative lab-confirmed influenza)'}, {'measure': 'Number of Adults 50-64 Years Old With All-Cause-Hospitalizations', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause hospitalizations'}, {'measure': 'Number of Adults 50-64 Years Old With All-Cause Mortality', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause mortality'}, {'measure': 'Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).'}, {'measure': 'Number of Adults 18-49 Years Old Hospitalized With PCR-confirmed Influenza', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay and had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).'}, {'measure': 'Number of Adults 18-49 Years Old Hospitalized With Cardio-respiratory Events', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for cardio-respiratory events (e.g., pneumonia, other lower respiratory infections, acute myocardial infarction, congestive heart failure, stroke) (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).'}, {'measure': 'Number of Adults 18-49 Years Old With Influenza-Like Illness (ILI)', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for influenza-like illness (ILI) International Classification of Diseases, 10th Edition (and absence of a negative lab-confirmed influenza)'}, {'measure': 'Number of Adults 18-49 Years Old With All-Cause-Hospitalizations', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause hospitalizations'}, {'measure': 'Number of Adults 18-49 Years Old With All-Cause Mortality', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30) for all-cause mortality'}, {'measure': 'Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza A test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).'}, {'measure': 'Number of Adults 18-49 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza B test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).'}], 'primaryOutcomes': [{'measure': 'Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).'}], 'secondaryOutcomes': [{'measure': 'Number of Adults 50-64 Years Old Hospitalized With PCR-confirmed Influenza', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay and had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).'}, {'measure': 'Number of Adults 50-64 Years Old Hospitalized With Community-acquired Pneumonia', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for community-acquired pneumonia (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).'}, {'measure': 'Number of Adults 50-64 Years Old Hospitalized With Cardio-respiratory Events', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had an inpatient stay for cardio-respiratory events (e.g., pneumonia, other lower respiratory infections, acute myocardial infarction, congestive heart failure, stroke) (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).'}, {'measure': 'Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza A test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).'}, {'measure': 'Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests', 'timeFrame': 'Up to 8 months', 'description': 'Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza B test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['influenza', 'vaccine effectiveness'], 'conditions': ['Influenza', 'Pneumonia', 'Lower Respiratory Tract Infection', 'Acute Myocardial Infarction', 'Congestive Heart Failure', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '39512761', 'type': 'DERIVED', 'citation': 'Hsiao A, Yee A, Izikson R, Fireman B, Hansen J, Lewis N, Gandhi-Banga S, Selmani A, Talanova O, Kabler H, Inamdar A, Klein NP. Safety of quadrivalent recombinant influenza vaccine in pregnant persons and their infants. AJOG Glob Rep. 2024 Sep 20;4(4):100395. doi: 10.1016/j.xagr.2024.100395. eCollection 2024 Nov.'}, {'pmid': '38091531', 'type': 'DERIVED', 'citation': 'Hsiao A, Yee A, Fireman B, Hansen J, Lewis N, Klein NP. Recombinant or Standard-Dose Influenza Vaccine in Adults under 65 Years of Age. N Engl J Med. 2023 Dec 14;389(24):2245-2255. doi: 10.1056/NEJMoa2302099.'}, {'pmid': '34998605', 'type': 'DERIVED', 'citation': 'Hsiao A, Hansen J, Nunley KV, Lewis N, Selmani A, Inamdar A, Mallett-Moore T, Izikson R, Rudin D, Klein NP. Safety of recombinant quadrivalent influenza vaccine compared to inactivated influenza vaccine in Chinese adults: An observational study. Vaccine. 2022 Jan 31;40(5):774-779. doi: 10.1016/j.vaccine.2021.12.035. Epub 2022 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to describe the effectiveness of Flublok Quadrivalent vaccine compared to standard dose inactivated influenza vaccine (SD-IIV) in adults 18 through 64 years of age. During this study, Flublok Quadrivalent or SD-IIV will be administered according to the guidelines in the Prescribing Information materials and only to persons for whom it is indicated. The 2018-2019, 2019-2020, and 2020-2021 formulations of recombinant influenza vaccine (Flublok Quadrivalent vaccine) and SD-IIV will be evaluated for outcomes including all polymerase chain reaction (PCR)-confirmed influenza, PCR-confirmed hospitalized influenza, hospitalized community-acquired pneumonia and cardio-respiratory events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible adults aged 18-64 years will receive either Flublok Quadrivalent vaccine or a standard dose inactivated influenza vaccine in the course of routine influenza vaccination during each of the two influenza seasons of the study period at Kaiser Permanente Northern California.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of ≥18 and \\<65 years at the time of influenza vaccination\n* Receive either Flublok Quadrivalent vaccine or standard dose inactivated influenza vaccine at a Kaiser Permanente Northern California facility during the study period from August 2018 through April 2020\n\nExclusion Criteria:\n\n* Children \\<18 years old\n* Adults ≥65 years old'}, 'identificationModule': {'nctId': 'NCT03694392', 'briefTitle': 'Flublok v. Standard Dose Vaccine Effectiveness Among Kaiser Permanente Northern California Adults 18-64 Years', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Examining Vaccine Effectiveness (VE) of Flublok Relative to Standard Dose Inactivated Influenza Vaccine Among Kaiser Permanente Northern California Members Aged 18-64 Years', 'orgStudyIdInfo': {'id': 'CN-18-3176'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Flublok Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.', 'interventionNames': ['Biological: Flublok Quadrivalent']}, {'label': 'SD-IIV Recipients', 'description': 'Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).', 'interventionNames': ['Biological: Standard Dose Inactivated Influenza Vaccine (SD-IIV)']}], 'interventions': [{'name': 'Flublok Quadrivalent', 'type': 'BIOLOGICAL', 'description': "Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs.", 'armGroupLabels': ['Flublok Recipients']}, {'name': 'Standard Dose Inactivated Influenza Vaccine (SD-IIV)', 'type': 'BIOLOGICAL', 'description': 'For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.', 'armGroupLabels': ['SD-IIV Recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Northern California (entire region)', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'Nicola P Klein, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All data reported to Sanofi Pasteur by the Kaiser Permanente Northern California Vaccine Study Center will be deidentified and aggregated.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}