Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT06199934
Status:
COMPLETED
Last Update Posted:
2025-09-10
First Post:
2023-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014611', 'term': 'Vaccination'}], 'ancestors': [{'id': 'D016233', 'term': 'Immunotherapy, Active'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011322', 'term': 'Primary Prevention'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003140', 'term': 'Communicable Disease Control'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '18007181021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events and death were not collected; hence, time frame was not applicable', 'description': 'In this observational retrospective study of deidentified database individual identifying information was not available. Minimum criteria for reporting an adverse event could not be met, hence SAEs and other AEs were not planned to be collected and reported.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants COVID-19 Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '210902', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)', 'description': 'Number of participants diagnosed with COVID-19 were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Outpatient Encounter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '130171', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)', 'description': 'Outpatient encounter was considered as an encounter with International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code: U07.1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Inpatient Encounter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '11172', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)', 'description': 'Inpatient encounter was considered as an encounter with ICD-10-CM code: U07.1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Emergency Department Encounter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '28010', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)', 'description': 'Number of emergency department encounter was considered as an encounter with ICD-10-CM code: U07.1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With COVID-19 Critical Illness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '3905', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)', 'description': 'COVID-19 critical illness was defined as intensive care unit \\[ICU\\] admission, mechanical ventilation, or inpatient death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Non-COVID-19 Respiratory Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '1869819', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)', 'description': 'Non-COVID-19 respiratory infection included: diagnosis of any of pneumonia, respiratory syncytial virus (RSV), rhinovirus and/or receipt of antibiotic prescription.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Negative Control Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '433934', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)', 'description': 'Negative outcomes included: accidental injury, ingrown toenail and atopic dermatitis. Number of participants with any negative control outcomes were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Total Costs of All-cause Hospitalizations From Administrative Healthcare Claims Dataset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '1008.21', 'spread': '8591.93', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)', 'unitOfMeasure': 'US Dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Average Length of Stay (LOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.11', 'spread': '7.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)', 'description': 'Average length of stay was defined as date of service end minus date of service start.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ICU Admission Are Included in This Outcome Measure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '2864', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)', 'description': 'Percentage of participants with ICU admission within 30 Days of follow-up are included in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received High-flow Oxygen or Mechanical Ventilation (MV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '863', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Inpatient Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for this outcome measure as mortality information in the HealthVerity data was delayed several months behind real time, to protect confidentiality, and were not available at the time of analyses for the study period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Antiviral Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '41774', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)', 'description': 'Number of participants who received antiviral COVID treatment is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Mean Cost of All-cause Healthcare From Administrative Healthcare Claims Dataset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '9563.85', 'spread': '134821.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)', 'unitOfMeasure': 'US Dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'All-cause Healthcare Resource Utilization as The Total Number of Encounters, Regardless of Setting, Using Data From Administrative Healthcare Claims Dataset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.04', 'spread': '19.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)', 'unitOfMeasure': 'Encounters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With COVID-19-Related Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '12129', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19853610'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19853610'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Data from adult and pediatric participants who were residents of California or Louisiana were collected from immunization registry linked to closed claims from HealthVerity in this retrospective study. Data was collected from HealthVerity Database from 11-Sep-2023 to 12-Mar-2024, available data was evaluated from 07-Feb-2024 to 31-Jul-2024.', 'preAssignmentDetails': 'A total of 19853610 participants were enrolled this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19702014', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '38.4', 'spread': '22.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic.'}, {'title': 'Sex/Gender, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19853610', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10455294', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9340840', 'groupId': 'BG000'}]}, {'title': 'Unknown/missing', 'measurements': [{'value': '57476', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-17', 'size': 5878366, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-31T13:49', 'hasProtocol': True}, {'date': '2024-06-11', 'size': 14635722, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-31T13:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19853610}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2023-12-18', 'resultsFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-21', 'studyFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants COVID-19 Diagnosis', 'timeFrame': 'From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)', 'description': 'Number of participants diagnosed with COVID-19 were reported in this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With an Outpatient Encounter', 'timeFrame': 'From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)', 'description': 'Outpatient encounter was considered as an encounter with International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code: U07.1.'}, {'measure': 'Number of Participants With an Inpatient Encounter', 'timeFrame': 'From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)', 'description': 'Inpatient encounter was considered as an encounter with ICD-10-CM code: U07.1.'}, {'measure': 'Number of Participants With Emergency Department Encounter', 'timeFrame': 'From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)', 'description': 'Number of emergency department encounter was considered as an encounter with ICD-10-CM code: U07.1.'}, {'measure': 'Number of Participants With COVID-19 Critical Illness', 'timeFrame': 'From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)', 'description': 'COVID-19 critical illness was defined as intensive care unit \\[ICU\\] admission, mechanical ventilation, or inpatient death.'}, {'measure': 'Number of Participants With Non-COVID-19 Respiratory Infection', 'timeFrame': 'From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)', 'description': 'Non-COVID-19 respiratory infection included: diagnosis of any of pneumonia, respiratory syncytial virus (RSV), rhinovirus and/or receipt of antibiotic prescription.'}, {'measure': 'Number of Participants With Negative Control Outcomes', 'timeFrame': 'From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)', 'description': 'Negative outcomes included: accidental injury, ingrown toenail and atopic dermatitis. Number of participants with any negative control outcomes were reported in this outcome measure.'}, {'measure': 'Total Costs of All-cause Hospitalizations From Administrative Healthcare Claims Dataset', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)'}, {'measure': 'Average Length of Stay (LOS)', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)', 'description': 'Average length of stay was defined as date of service end minus date of service start.'}, {'measure': 'Number of Participants With ICU Admission Are Included in This Outcome Measure.', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)', 'description': 'Percentage of participants with ICU admission within 30 Days of follow-up are included in this outcome measure.'}, {'measure': 'Number of Participants Who Received High-flow Oxygen or Mechanical Ventilation (MV)', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)'}, {'measure': 'Number of Participants With Inpatient Mortality', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)'}, {'measure': 'Number of Participants Who Received Antiviral Treatment', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)', 'description': 'Number of participants who received antiviral COVID treatment is reported.'}, {'measure': 'Mean Cost of All-cause Healthcare From Administrative Healthcare Claims Dataset', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)'}, {'measure': 'All-cause Healthcare Resource Utilization as The Total Number of Encounters, Regardless of Setting, Using Data From Administrative Healthcare Claims Dataset', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)'}, {'measure': 'Number of Participants With COVID-19-Related Hospitalization', 'timeFrame': 'From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'XBB vaccine effectiveness'], 'conditions': ['SARS-CoV-2', 'COVID-19 Vaccines']}, 'referencesModule': {'references': [{'pmid': '40818804', 'type': 'DERIVED', 'citation': 'Andersen KM, McColgan MD, Mateus JS, Yu T, Zhou A, Puzniak L, Lopez SMC. BNT162b2 XBB.1.5-Adapted Single Dose Vaccine Uptake and Effectiveness in Children Aged 5-17 Years Using Linked Claims and Vaccine Registries in California and Louisiana. J Pediatr. 2025 Nov;286:114778. doi: 10.1016/j.jpeds.2025.114778. Epub 2025 Aug 14.'}, {'pmid': '39987879', 'type': 'DERIVED', 'citation': 'Andersen KM, Allen KE, Nepal RM, Mateus JS, Yu T, Zhou A, Porter TM, Lopez SMC, Puzniak L, McLaughlin JM, McGrath LJ. Effectiveness of BNT162b2 XBB.1.5 vaccine in immunocompetent adults using tokenization in two U.S. states. Vaccine. 2025 Apr 11;52:126881. doi: 10.1016/j.vaccine.2025.126881. Epub 2025 Feb 22.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4591065', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to learn about how well different versions of the Pfizer-BioNTech COVID-19 vaccine (called BNT162b2) work at preventing death, severe COVID-19 that requires a trip to the hospital, and overall use of healthcare resources, such as needing to go the doctor or urgent care due to illness. Pfizer is not enrolling any participants for this study. Instead, existing data from different health data sources will be used to help answer the scientific questions Pfizer is interested in learning more about.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were California or Louisiana residents in the HealthVerity claims database will be defined using the following hierarchical definition:\n\n1. Persons who have their enrollment file record indicating a patient location of California or Louisiana in HealthVerity claims enrollment file.\n2. Persons who have a patient state location other than California or Louisiana in HealthVerity claims enrollment but have one or more records in the California or Louisiana Immunization Registry. Examples include people who previously lived in Texas but moved to California and received a vaccine, or persons who crossed state lines for a vaccine and remain in their non-California state in claims data.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with at least one year of pharmacy and medical enrollment in HealthVerity prior to vaccine availability\n* State of California or Louisiana resident for at least one year\n\nExclusion criteria:\n\n* People currently pregnant,\n* Individuals with discrepancies in sex and/or year of birth between HealthVerity claims and California/Louisiana immunization registry datasets\n* A diagnosis of COVID-19 in any setting ≤ 90 days prior to start of study or receipt COVID-19 vaccine ≤ 90 days prior to start of study.'}, 'identificationModule': {'nctId': 'NCT06199934', 'briefTitle': 'Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data', 'orgStudyIdInfo': {'id': 'C4591065'}, 'secondaryIdInfos': [{'id': 'RAVEN', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vaccinated', 'description': 'BNT162b2 recipients', 'interventionNames': ['Biological: Vaccination']}, {'label': 'Unvaccinated', 'description': 'BNT162b2 eligible but did not receive'}], 'interventions': [{'name': 'Vaccination', 'type': 'BIOLOGICAL', 'description': 'BNT162b2 vaccination', 'armGroupLabels': ['Vaccinated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Global Headquarters', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}