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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Same day | Pfizer-BioNTech mRNA bivalent COVID and flu on the same day |
| |
| COVID alone | Pfizer-BioNTech bivalent COVID only |
| |
| flu alone | influenza vaccine of any type only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comirnaty | Biological | COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old | 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. | 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) |
| Number of Participants With All Cause Hospitalization Visits: >=65 Years Old | 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. | 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) |
| Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus COVID-19 Alone | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include adults patients who were enrolled in the Optum Clinformatics Database as of 31 August 2022
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | New York | New York | 10001 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1a: Same Day COVID-19 Vaccine and SIV, 18-64 Years | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2023 |
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| Quadrivalent Influenza Vaccine | Biological | 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 |
|
| 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) |
| Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone | 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. | 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) |
| Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus COVID-19 Alone | 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. | 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) |
| Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus SIV Alone | 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. | 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) |
| Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus COVID-19 Alone | 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. | 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) |
| Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus SIV Alone | 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. | 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) |
| Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus COVID-19 Alone | 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. | 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) |
| Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus SIV Alone | 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. | 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) |
| Group 2a: COVID-19 Vaccine Alone, 18-64 Years |
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. |
| FG002 | Group 3a: SIV Alone, 18-64 Years | 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. |
| FG003 | Group 1b: Same Day COVID-19 Vaccine and SIV, >= 65 Years | 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. |
| FG004 | Group 2b: COVID-19 Vaccine Alone, >=65 Years | 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. |
| FG005 | Group 3b: SIV Alone, >=65 Years | 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. |
| COMPLETED |
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| NOT COMPLETED |
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All eligible participants whose data were observed in this retrospective observational study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1a: Same Day COVID-19 Vaccine and SIV, 18-64 Years | 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. |
| BG001 | Group 2a: COVID-19 Vaccine Alone, 18-64 Years | 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. |
| BG002 | Group 3a: SIV Alone, 18-64 Years | 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. |
| BG003 | Group 1b: Same Day COVID-19 Vaccine and SIV, >= 65 Years | 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. |
| BG004 | Group 2b: COVID-19 Vaccine Alone, >=65 Years | 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. |
| BG005 | Group 3b: SIV Alone, >=65 Years | 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race/ethnicity data was not available. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old | 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. | 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). | Posted | Count of Participants | Participants | 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) |
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| Primary | Number of Participants With All Cause Hospitalization Visits: >=65 Years Old | 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. | 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). | Posted | Count of Participants | Participants | 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) |
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| Primary | Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus COVID-19 Alone | 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. | 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). | Posted | Count of Participants | Participants | 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) |
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| Primary | Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone | 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. | 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). | Posted | Count of Participants | Participants | 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) |
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| Primary | Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus COVID-19 Alone | 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. | 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). | Posted | Count of Participants | Participants | 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) |
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| Primary | Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus SIV Alone | 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. | 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). | Posted | Count of Participants | Participants | 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) |
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| Primary | Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus COVID-19 Alone | 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. | 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). | Posted | Count of Participants | Participants | 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) |
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| Primary | Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus SIV Alone | 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. | 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). | Posted | Count of Participants | Participants | 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) |
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| Primary | Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus COVID-19 Alone | 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. | 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). | Posted | Count of Participants | Participants | 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) |
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| Primary | Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus SIV Alone | 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. | 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). | Posted | Count of Participants | Participants | 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) |
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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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1a: Same Day COVID-19 Vaccine and SIV, 18-64 Years | 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. | 110 | 244,900 | 0 | 0 | 0 | 0 |
| EG001 | Group 2a: COVID-19 Vaccine Alone, 18-64 Years | 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. | 63 | 143,743 | 0 | 0 | 0 | 0 |
| EG002 | Group 3a: SIV Alone, 18-64 Years | 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. | 794 | 843,860 | 0 | 0 | 0 | 0 |
| EG003 | Group 1b: Same Day COVID-19 Vaccine and SIV, >= 65 Years | 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. | 2,160 | 382,835 | 0 | 0 | 0 | 0 |
| EG004 | Group 2b: COVID-19 Vaccine Alone, >=65 Years | 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. | 1,402 | 225,680 | 0 | 0 | 0 | 0 |
| EG005 | Group 3b: SIV Alone, >=65 Years | 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. | 12,031 | 1,601,978 | 0 | 0 | 0 | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquires@pfizer.com |
| May 6, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
Not provided
Not provided
| 65 years and above |
|
| Male |
|
| Unknown |
|
To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.
| Weighted Hazard Ratio |
| 0.634 |
| 2-Sided |
| 95 |
| 0.606 |
| 0.664 |
| Other |
| Group 2b, Model 1: COVID-19 Vaccine Alone, >=65 Years |
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. |
| OG002 | Group 1b, Model 2: Same Day (COVID-19 Vaccine and SIV), >=65 Years | 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. |
| OG003 | Group 3b, Model 2: SIV Alone, >=65 Years | 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. |
|
|
|
| Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years |
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. |
| OG002 | Group 1b, Model 1: Same Day (COVID-19 Vaccine and SIV), >=65 Years | 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. |
| OG003 | Group 2b, Model 1: COVID-19 Vaccine Alone, >=65 Years | 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. |
|
|
|
| OG001 |
| Group 3a, Model 2: SIV Alone, 18-64 Years |
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. |
| OG002 | Group 1b, Model 2: Same Day (COVID-19 Vaccine and SIV), >=65 Years | 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. |
| OG003 | Group 3b, Model 2: SIV Alone, >=65 Years | 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. |
|
|
|
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. |
| OG002 | Group 1b, Model 1: Same Day (COVID-19 Vaccine and SIV), >=65 Years | 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. |
| OG003 | Group 2b, Model 1: COVID-19 Vaccine Alone, >=65 Years | 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. |
|
|
|
| Group 3a, Model 2: SIV Alone, 18-64 Years |
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. |
| OG002 | Group 1b, Model 2: Same Day (COVID-19 Vaccine and SIV), >=65 Years | 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. |
| OG003 | Group 3b, Model 2: SIV Alone, >=65 Years | 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. |
|
|
|
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.
| OG002 | Group 1b, Model 1: Same Day (COVID-19 Vaccine and SIV), >=65 Years | 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. |
| OG003 | Group 2b, Model 1: COVID-19 Vaccine Alone, >=65 Years | 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. |
|
|
|
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. |
| OG002 | Group 1b, Model 2: Same Day (COVID-19 Vaccine and SIV), >=65 Years | 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. |
| OG003 | Group 3b, Model 2: SIV Alone, >=65 Years | 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. |
|
|
|
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.
| OG002 | Group 1b, Model 1: Same Day (COVID-19 Vaccine and SIV), >=65 Years | 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. |
| OG003 | Group 2b, Model 1: COVID-19 Vaccine Alone, >=65 Years | 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. |
|
|
|
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. |
| OG002 | Group 1b, Model 2: Same Day (COVID-19 Vaccine and SIV), >=65 Years | 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. |
| OG003 | Group 3b, Model 2: SIV Alone, >=65 Years | 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. |
|
|
|