Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-27 @ 5:16 AM
Study NCT ID:
NCT05858450
Status:
COMPLETED
Last Update Posted:
2024-09-20
First Post:
2023-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
This Study Intends to Describe the Characteristics of Patients Given the Pfizer-BioNTech Bivalent mRNA COVID-19 Vaccine and Any Commercially Available Influenza Vaccines at the Same Time Versus at Different Times.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D000086382', 'term': 'COVID-19'}], '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': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090982', 'term': 'BNT162 Vaccine'}, {'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D000087503', 'term': 'mRNA Vaccines'}, {'id': 'D000087504', 'term': 'Nucleic Acid-Based Vaccines'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquires@pfizer.com', 'phone': '1-800-718-1021', '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 publications 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}, 'limitationsAndCaveats': {'description': '1. COVID-19 and influenza vaccinations may have been under-ascertained.\n2. The study population included employer-sponsored health plans and Medicare Advantage, which may limit generalizability.\n3. It was possible that unmeasured residual confounding remained.\n4. Effectiveness for individual influenza vaccines was not assessed.\n5. COVID-19 and influenza endpoints were identified using diagnosis codes rather than via laboratory confirmation.\n6. This study included only one respiratory virus season.'}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality: From Day 1 of vaccination till end of follow-up observation period (approx. 5.5 months, data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 [8 days]); SAEs and Other AEs: Not applicable as safety data not collected.', 'description': 'This observational retrospective study used de-identified data from Optum Clinformatics Database. In this data source, 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': 'Group 1a: Same Day COVID-19 Vaccine and SIV, 18-64 Years', 'description': 'Participants included in this group were aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 244900, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 110, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2a: COVID-19 Vaccine Alone, 18-64 Years', 'description': 'Participants included in this group were aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine alone any time between 31 August 2022 and 30 January 2023.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 143743, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 63, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3a: SIV Alone, 18-64 Years', 'description': 'Participants included in this group were aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received SIV alone any time between 31 August 2022 and 30 January 2023.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 843860, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 794, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group 1b: Same Day COVID-19 Vaccine and SIV, >= 65 Years', 'description': 'Participants included in this group were aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV (enhanced) on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 382835, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 2160, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Group 2b: COVID-19 Vaccine Alone, >=65 Years', 'description': 'Participants included in this group were aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine alone any time between 31 August 2022 and 30 January 2023.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 225680, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 1402, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Group 3b: SIV Alone, >=65 Years', 'description': 'Participants included in this group were aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received SIV (enhanced) alone any time between 31 August 2022 and 30 January 2023.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 1601978, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 12031, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244900', 'groupId': 'OG000'}, {'value': '143743', 'groupId': 'OG001'}, {'value': '244820', 'groupId': 'OG002'}, {'value': '843412', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG001', 'title': 'Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received only COVID-19 vaccine anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG002', 'title': 'Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023. This arm excluded participants with unknown/other region.'}, {'id': 'OG003', 'title': 'Group 3a, Model 2: SIV Alone, 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received only SIV anytime between 31 August 2022 and 30 January 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '1838', 'groupId': 'OG000'}, {'value': '705', 'groupId': 'OG001'}, {'value': '1837', 'groupId': 'OG002'}, {'value': '12715', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.108', 'ciLowerLimit': '1.018', 'ciUpperLimit': '1.205', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an inverse probability of treatment weights (IPTW) was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.634', 'ciLowerLimit': '0.606', 'ciUpperLimit': '0.664', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs Flu (SIV) alone.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were observed in this study. This outcome measure presents reporting arms as planned based on the following: participants 18-64 years of age for both models: Model 1 (reporting arms included were co-administration of vaccines on the same day and COVID-19 alone), Model 2 (reporting arms included were co-administration of vaccines on the same day \\[excluded participants with unknown/other region\\] and SIV alone).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With All Cause Hospitalization Visits: >=65 Years Old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382835', 'groupId': 'OG000'}, {'value': '225680', 'groupId': 'OG001'}, {'value': '382626', 'groupId': 'OG002'}, {'value': '1600981', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1b, Model 1: Same Day (COVID-19 Vaccine and SIV), >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV (enhanced) on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG001', 'title': 'Group 2b, Model 1: COVID-19 Vaccine Alone, >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG002', 'title': 'Group 1b, Model 2: Same Day (COVID-19 Vaccine and SIV), >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV (enhanced) on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023. This arm excluded participants with unknown/other region.'}, {'id': 'OG003', 'title': 'Group 3b, Model 2: SIV Alone, >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received SIV (enhanced) anytime between 31 August 2022 and 30 January 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '7753', 'groupId': 'OG000'}, {'value': '2719', 'groupId': 'OG001'}, {'value': '7751', 'groupId': 'OG002'}, {'value': '33926', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.061', 'ciLowerLimit': '1.016', 'ciUpperLimit': '1.107', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.897', 'ciLowerLimit': '0.875', 'ciUpperLimit': '0.919', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were observed in this study. This outcome measure presents reporting arms as planned based on the following: participants \\>=65 years of age for both models: Model 1 (reporting arms included were co-administration of vaccines on the same day and COVID-19 alone), Model 2 (reporting arms included were co-administration of vaccines on the same day \\[excluded participants with unknown/other region\\] and SIV alone).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus COVID-19 Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244900', 'groupId': 'OG000'}, {'value': '143743', 'groupId': 'OG001'}, {'value': '382835', 'groupId': 'OG002'}, {'value': '225680', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG001', 'title': 'Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received only COVID-19 vaccine anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG002', 'title': 'Group 1b, Model 1: Same Day (COVID-19 Vaccine and SIV), >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV (enhanced) on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG003', 'title': 'Group 2b, Model 1: COVID-19 Vaccine Alone, >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine anytime between 31 August 2022 and 30 January 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '2085', 'groupId': 'OG002'}, {'value': '684', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.543', 'ciLowerLimit': '1.133', 'ciUpperLimit': '2.1', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.106', 'ciLowerLimit': '1.014', 'ciUpperLimit': '1.206', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'Hospitalization, emergency department or urgent care visits with COVID-19 diagnosis code (International Classification of Diseases, 10th revision \\[ICD-10-CM\\]: U07.1) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were observed in this retrospective observational study. This outcome measure presents reporting arms as planned based on the following: participants 18-64 years and \\>=65 years of age for Model 1 (reporting arms included were co-administration of vaccines on the same day and COVID-19 alone).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244820', 'groupId': 'OG000'}, {'value': '843412', 'groupId': 'OG001'}, {'value': '382626', 'groupId': 'OG002'}, {'value': '1600981', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023. This arm excluded participants with unknown/other region.'}, {'id': 'OG001', 'title': 'Group 3a, Model 2: SIV Alone, 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received only SIV anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG002', 'title': 'Group 1b, Model 2: Same Day (COVID-19 Vaccine and SIV), >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV (enhanced) on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023. This arm excluded participants with unknown/other region.'}, {'id': 'OG003', 'title': 'Group 3b, Model 2: SIV Alone, >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received SIV (enhanced) anytime between 31 August 2022 and 30 January 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '770', 'groupId': 'OG001'}, {'value': '953', 'groupId': 'OG002'}, {'value': '3936', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.048', 'ciLowerLimit': '0.903', 'ciUpperLimit': '1.217', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.908', 'ciLowerLimit': '0.846', 'ciUpperLimit': '0.973', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'Hospitalization, emergency department or urgent care visits with Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were observed in this retrospective observational study. This outcome measure presents reporting arms as planned based on the following: participants 18-64 years and \\>=65 years of age for Model 2 (reporting arms included were co-administration of vaccines on the same day \\[excluded participants with unknown/other region\\] and SIV alone).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus COVID-19 Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244900', 'groupId': 'OG000'}, {'value': '143743', 'groupId': 'OG001'}, {'value': '382835', 'groupId': 'OG002'}, {'value': '225680', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG001', 'title': 'Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received only COVID-19 vaccine anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG002', 'title': 'Group 1b, Model 1: Same Day (COVID-19 Vaccine and SIV), >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV (enhanced) on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG003', 'title': 'Group 2b, Model 1: COVID-19 Vaccine Alone, >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine anytime between 31 August 2022 and 30 January 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '3513', 'groupId': 'OG000'}, {'value': '1399', 'groupId': 'OG001'}, {'value': '6473', 'groupId': 'OG002'}, {'value': '2268', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.137', 'ciLowerLimit': '1.068', 'ciUpperLimit': '1.211', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.057', 'ciLowerLimit': '1.007', 'ciUpperLimit': '1.11', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, (from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'COVID-19 diagnosis code (ICD-10-CM: U07.1) in any position. An outpatient visit refers to any encounter that is in the outpatient setting. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were observed in this retrospective observational study. This outcome measure presents reporting arms as planned based on the following: participants 18-64 years and \\>=65 years of age for Model 1 (reporting arms included were co-administration of vaccines on the same day and COVID-19 alone).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus SIV Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244820', 'groupId': 'OG000'}, {'value': '843412', 'groupId': 'OG001'}, {'value': '382626', 'groupId': 'OG002'}, {'value': '1600981', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023. This arm excluded participants with unknown/other region.'}, {'id': 'OG001', 'title': 'Group 3a, Model 2: SIV Alone, 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received only SIV anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG002', 'title': 'Group 1b, Model 2: Same Day (COVID-19 Vaccine and SIV), >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV (enhanced) on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023. This arm excluded participants with unknown/other region.'}, {'id': 'OG003', 'title': 'Group 3b, Model 2: SIV Alone, >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received SIV (enhanced) anytime between 31 August 2022 and 30 January 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '1346', 'groupId': 'OG000'}, {'value': '6200', 'groupId': 'OG001'}, {'value': '1457', 'groupId': 'OG002'}, {'value': '6396', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.761', 'ciLowerLimit': '0.718', 'ciUpperLimit': '0.807', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.858', 'ciLowerLimit': '0.811', 'ciUpperLimit': '0.907', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. An outpatient visit refers to any encounter that is in the outpatient setting. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were observed in this retrospective observational study. This outcome measure presents reporting arms as planned based on the following: participants 18-64 years and \\>=65 years of age for Model 2 (reporting arms included were co-administration of vaccines on the same day \\[excluded participants with unknown/other region\\] and SIV alone).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus COVID-19 Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244900', 'groupId': 'OG000'}, {'value': '143743', 'groupId': 'OG001'}, {'value': '382835', 'groupId': 'OG002'}, {'value': '225680', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG001', 'title': 'Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received only COVID-19 vaccine anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG002', 'title': 'Group 1b, Model 1: Same Day (COVID-19 Vaccine and SIV), >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV (enhanced) on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG003', 'title': 'Group 2b, Model 1: COVID-19 Vaccine Alone, >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine anytime between 31 August 2022 and 30 January 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '452', 'groupId': 'OG002'}, {'value': '164', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.55', 'ciLowerLimit': '0.88', 'ciUpperLimit': '2.731', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.035', 'ciLowerLimit': '0.865', 'ciUpperLimit': '1.238', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'COVID-19 diagnosis code (ICD-10-CM: U07.1) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were observed in this retrospective observational study. This outcome measure presents reporting arms as planned based on the following: participants 18-64 years and \\>=65 years of age for Model 1 (reporting arms included were co-administration of vaccines on the same day and COVID-19 alone).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus SIV Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244820', 'groupId': 'OG000'}, {'value': '843412', 'groupId': 'OG001'}, {'value': '382626', 'groupId': 'OG002'}, {'value': '1600981', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023. This arm excluded participants with unknown/other region.'}, {'id': 'OG001', 'title': 'Group 3a, Model 2: SIV Alone, 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received only SIV anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG002', 'title': 'Group 1b, Model 2: Same Day (COVID-19 Vaccine and SIV), >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV (enhanced) on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023. This arm excluded participants with unknown/other region.'}, {'id': 'OG003', 'title': 'Group 3b, Model 2: SIV Alone, >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received SIV (enhanced) anytime between 31 August 2022 and 30 January 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '1164', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.921', 'ciLowerLimit': '0.687', 'ciUpperLimit': '1.233', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.826', 'ciLowerLimit': '0.722', 'ciUpperLimit': '0.945', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, (from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were observed in this retrospective observational study. This outcome measure presents reporting arms as planned based on the following: participants 18-64 years and \\>=65 years of age for Model 2 (reporting arms included were co-administration of vaccines on the same day \\[excluded participants with unknown/other region\\] and SIV alone).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus COVID-19 Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244900', 'groupId': 'OG000'}, {'value': '143743', 'groupId': 'OG001'}, {'value': '382835', 'groupId': 'OG002'}, {'value': '225680', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG001', 'title': 'Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received only COVID-19 vaccine anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG002', 'title': 'Group 1b, Model 1: Same Day (COVID-19 Vaccine and SIV), >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV (enhanced) on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG003', 'title': 'Group 2b, Model 1: COVID-19 Vaccine Alone, >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine anytime between 31 August 2022 and 30 January 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '1674', 'groupId': 'OG002'}, {'value': '535', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.569', 'ciLowerLimit': '1.088', 'ciUpperLimit': '2.264', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.118', 'ciLowerLimit': '1.015', 'ciUpperLimit': '1.233', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'COVID-19 diagnosis code (ICD-10-CM: U07.1) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were observed in this retrospective observational study. This outcome measure presents reporting arms as planned based on the following: participants 18-64 years and \\>=65 years of age for Model 1 (reporting arms included were co-administration of vaccines on the same day and COVID-19 alone).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus SIV Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244820', 'groupId': 'OG000'}, {'value': '843412', 'groupId': 'OG001'}, {'value': '382626', 'groupId': 'OG002'}, {'value': '1600981', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023. This arm excluded participants with unknown/other region.'}, {'id': 'OG001', 'title': 'Group 3a, Model 2: SIV Alone, 18-64 Years', 'description': 'Participants aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received only SIV anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'OG002', 'title': 'Group 1b, Model 2: Same Day (COVID-19 Vaccine and SIV), >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV (enhanced) on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023. This arm excluded participants with unknown/other region.'}, {'id': 'OG003', 'title': 'Group 3b, Model 2: SIV Alone, >=65 Years', 'description': 'Participants aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received SIV (enhanced) anytime between 31 August 2022 and 30 January 2023.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '558', 'groupId': 'OG001'}, {'value': '736', 'groupId': 'OG002'}, {'value': '2870', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.082', 'ciLowerLimit': '0.911', 'ciUpperLimit': '1.286', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Weighted Hazard Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.932', 'ciLowerLimit': '0.859', 'ciUpperLimit': '1.01', 'groupDescription': 'To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, (from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were observed in this retrospective observational study. This outcome measure presents reporting arms as planned based on the following: participants 18-64 years and \\>=65 years of age for Model 2 (reporting arms included were co-administration of vaccines on the same day \\[excluded participants with unknown/other region\\] and SIV alone).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1a: Same Day COVID-19 Vaccine and SIV, 18-64 Years', 'description': 'Participants included in this group were aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'FG001', 'title': 'Group 2a: COVID-19 Vaccine Alone, 18-64 Years', 'description': 'Participants included in this group were aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine alone any time between 31 August 2022 and 30 January 2023.'}, {'id': 'FG002', 'title': 'Group 3a: SIV Alone, 18-64 Years', 'description': 'Participants included in this group were aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received SIV alone any time between 31 August 2022 and 30 January 2023.'}, {'id': 'FG003', 'title': 'Group 1b: Same Day COVID-19 Vaccine and SIV, >= 65 Years', 'description': 'Participants included in this group were aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV (enhanced) on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'FG004', 'title': 'Group 2b: COVID-19 Vaccine Alone, >=65 Years', 'description': 'Participants included in this group were aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine alone any time between 31 August 2022 and 30 January 2023.'}, {'id': 'FG005', 'title': 'Group 3b: SIV Alone, >=65 Years', 'description': 'Participants included in this group were aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received SIV (enhanced) alone any time between 31 August 2022 and 30 January 2023.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '244900'}, {'groupId': 'FG001', 'numSubjects': '143743'}, {'groupId': 'FG002', 'numSubjects': '843860'}, {'groupId': 'FG003', 'numSubjects': '382835'}, {'groupId': 'FG004', 'numSubjects': '225680'}, {'groupId': 'FG005', 'numSubjects': '1601978'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '244900'}, {'groupId': 'FG001', 'numSubjects': '143743'}, {'groupId': 'FG002', 'numSubjects': '843860'}, {'groupId': 'FG003', 'numSubjects': '382835'}, {'groupId': 'FG004', 'numSubjects': '225680'}, {'groupId': 'FG005', 'numSubjects': '1601978'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Adult participants (greater than or equal to \\[\\>=\\] 18 years) who were enrolled in the Optum Clinformatics Database as of 31 August 2022 and had received a Pfizer-BioNTech messenger ribonucleic acid (mRNA) bivalent COVID-19 vaccine and/or seasonal influenza/flu vaccine (SIV) anytime between 31 August 2022 and 30 January 2023 were included in this retrospective, observational study.', 'preAssignmentDetails': 'Outcome measures were compared using Cox Proportional Hazards models for the following exposure groups: comparison 1: co-administration of vaccines on the same day and COVID-19 vaccine alone, comparison 2: co-administration of vaccines on the same day (excluded participants with unknown/other region) and SIV alone.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '244900', 'groupId': 'BG000'}, {'value': '143743', 'groupId': 'BG001'}, {'value': '843860', 'groupId': 'BG002'}, {'value': '382835', 'groupId': 'BG003'}, {'value': '225680', 'groupId': 'BG004'}, {'value': '1601978', 'groupId': 'BG005'}, {'value': '3442996', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1a: Same Day COVID-19 Vaccine and SIV, 18-64 Years', 'description': 'Participants included in this group were aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'BG001', 'title': 'Group 2a: COVID-19 Vaccine Alone, 18-64 Years', 'description': 'Participants included in this group were aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine alone any time between 31 August 2022 and 30 January 2023.'}, {'id': 'BG002', 'title': 'Group 3a: SIV Alone, 18-64 Years', 'description': 'Participants included in this group were aged 18-64 years, who were enrolled in the Optum Clinformatics Database and received SIV alone any time between 31 August 2022 and 30 January 2023.'}, {'id': 'BG003', 'title': 'Group 1b: Same Day COVID-19 Vaccine and SIV, >= 65 Years', 'description': 'Participants included in this group were aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine and SIV (enhanced) on the same day (co-administration) anytime between 31 August 2022 and 30 January 2023.'}, {'id': 'BG004', 'title': 'Group 2b: COVID-19 Vaccine Alone, >=65 Years', 'description': 'Participants included in this group were aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received COVID-19 vaccine alone any time between 31 August 2022 and 30 January 2023.'}, {'id': 'BG005', 'title': 'Group 3b: SIV Alone, >=65 Years', 'description': 'Participants included in this group were aged 65 years and above, who were enrolled in the Optum Clinformatics Database and received SIV (enhanced) alone any time between 31 August 2022 and 30 January 2023.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '18-64 years', 'measurements': [{'value': '244900', 'groupId': 'BG000'}, {'value': '143743', 'groupId': 'BG001'}, {'value': '843860', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1232503', 'groupId': 'BG006'}]}, {'title': '65 years and above', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '382835', 'groupId': 'BG003'}, {'value': '225680', 'groupId': 'BG004'}, {'value': '1601978', 'groupId': 'BG005'}, {'value': '2210493', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '127108', 'groupId': 'BG000'}, {'value': '78029', 'groupId': 'BG001'}, {'value': '477067', 'groupId': 'BG002'}, {'value': '208166', 'groupId': 'BG003'}, {'value': '132345', 'groupId': 'BG004'}, {'value': '939216', 'groupId': 'BG005'}, {'value': '1961931', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '117692', 'groupId': 'BG000'}, {'value': '65655', 'groupId': 'BG001'}, {'value': '366067', 'groupId': 'BG002'}, {'value': '174651', 'groupId': 'BG003'}, {'value': '93327', 'groupId': 'BG004'}, {'value': '661737', 'groupId': 'BG005'}, {'value': '1479129', 'groupId': 'BG006'}]}, {'title': 'Unknown', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '726', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '1025', 'groupId': 'BG005'}, {'value': '1936', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Data not available', 'measurements': [{'value': '244900', 'groupId': 'BG000'}, {'value': '143743', 'groupId': 'BG001'}, {'value': '843860', 'groupId': 'BG002'}, {'value': '382835', 'groupId': 'BG003'}, {'value': '225680', 'groupId': 'BG004'}, {'value': '1601978', 'groupId': 'BG005'}, {'value': '3442996', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race/ethnicity data was not available.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All eligible participants whose data were observed in this retrospective observational study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-26', 'size': 365836, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-06T14:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3442996}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2023-05-11', 'resultsFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-06', 'studyFirstPostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs Flu (SIV) alone.'}, {'measure': 'Number of Participants With All Cause Hospitalization Visits: >=65 Years Old', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone.'}, {'measure': 'Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus COVID-19 Alone', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'Hospitalization, emergency department or urgent care visits with COVID-19 diagnosis code (International Classification of Diseases, 10th revision \\[ICD-10-CM\\]: U07.1) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.'}, {'measure': 'Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'Hospitalization, emergency department or urgent care visits with Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.'}, {'measure': 'Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus COVID-19 Alone', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, (from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'COVID-19 diagnosis code (ICD-10-CM: U07.1) in any position. An outpatient visit refers to any encounter that is in the outpatient setting. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.'}, {'measure': 'Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus SIV Alone', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. An outpatient visit refers to any encounter that is in the outpatient setting. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.'}, {'measure': 'Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus COVID-19 Alone', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'COVID-19 diagnosis code (ICD-10-CM: U07.1) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.'}, {'measure': 'Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus SIV Alone', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, (from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.'}, {'measure': 'Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus COVID-19 Alone', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'COVID-19 diagnosis code (ICD-10-CM: U07.1) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.'}, {'measure': 'Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus SIV Alone', 'timeFrame': 'From Day 15 of vaccination till end of follow-up observation period, (from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)', 'description': 'Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Influenza, Human', 'COVID-19']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4591061', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study intends to describe the characteristics of patients given the Pfizer-BioNTech bivalent mRNA COVID-19 vaccine and any commercially available influenza vaccines at the same time versus at different times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include adults patients who were enrolled in the Optum Clinformatics Database as of 31 August 2022', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in Optum claims database as of 31 August 2022 (date bivalent authorized).\n* Has a Pfizer-BioNTech mRNA bivalent COVID-19 or influenza vaccine (any type) between 31 August 2022 and 30 January 2023 (earliest vaccine is index date).\n* Aged \\>=18 years on the index date\n* 365 days of continuous enrolment prior to index date\n\nExclusion Criteria:\n\n* Patients with a second dose of any type of bivalent mRNA COVID-19 or flu vaccine, disenrolled or died within 14 days following the first dose.\n* Has prior COVID-19 diagnosis (U07.1, any setting, any position) within 90 days (per CDC guidance on length of time before receiving a vaccine) before and on index.\n* Has influenza vaccine between 01 August -30 August 2022 (before study period).\n* Has a COVID-19 or influenza diagnosis code in any setting within 14 days after index vaccination (excluded from all cohorts).'}, 'identificationModule': {'nctId': 'NCT05858450', 'briefTitle': 'This Study Intends to Describe the Characteristics of Patients Given the Pfizer-BioNTech Bivalent mRNA COVID-19 Vaccine and Any Commercially Available Influenza Vaccines at the Same Time Versus at Different Times.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Investigating Uptake and Subsequent Health Outcomes Associated With Pfizer-BioNTech Bivalent COVID-19/Influenza Vaccine Concomitant Administration Using a Claims-based Real-world Data Source in the US', 'orgStudyIdInfo': {'id': 'C4591061'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Same day', 'description': 'Pfizer-BioNTech mRNA bivalent COVID and flu on the same day', 'interventionNames': ['Biological: Comirnaty', 'Biological: Quadrivalent Influenza Vaccine']}, {'label': 'COVID alone', 'description': 'Pfizer-BioNTech bivalent COVID only', 'interventionNames': ['Biological: Comirnaty']}, {'label': 'flu alone', 'description': 'influenza vaccine of any type only', 'interventionNames': ['Biological: Quadrivalent Influenza Vaccine']}], 'interventions': [{'name': 'Comirnaty', 'type': 'BIOLOGICAL', 'description': 'COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.', 'armGroupLabels': ['COVID alone', 'Same day']}, {'name': 'Quadrivalent Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': 'Quadrivalent Influenza Vaccine is a class of vaccines indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccines', 'armGroupLabels': ['Same day', 'flu alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer', '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'}}}}