COVID-19, Influenza, Human
Conditions
Brief summary
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.
Interventions
BIOLOGICALComirnaty
COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
BIOLOGICALQuadrivalent Influenza Vaccine
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
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enrolled in Optum claims database as of 31 August 2022 (date bivalent authorized). * 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). * Aged \>=18 years on the index date * 365 days of continuous enrolment prior to index date
Exclusion criteria
* 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. * 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. * Has influenza vaccine between 01 August -30 August 2022 (before study period). * Has a COVID-19 or influenza diagnosis code in any setting within 14 days after index vaccination (excluded from all cohorts).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old | 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) | 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. |
| Number of Participants With All Cause Hospitalization Visits: >=65 Years Old | 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) | 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. |
| Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus 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) | 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. |
| Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus 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) | 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. |
| Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus 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) | 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. |
| Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus 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) | 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. |
| Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus 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) | 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. |
| Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus 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) | 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. |
| Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus 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) | 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. |
| Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus 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) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 244,900 |
| 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. | 143,743 |
| 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. | 843,860 |
| 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. | 382,835 |
| 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. | 225,680 |
| 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. | 1,601,978 |
| Total | 3,442,996 |
Baseline characteristics
| Characteristic | Group 1a: Same Day COVID-19 Vaccine and SIV, 18-64 Years | Group 2a: COVID-19 Vaccine Alone, 18-64 Years | Group 3a: SIV Alone, 18-64 Years | Group 1b: Same Day COVID-19 Vaccine and SIV, >= 65 Years | Group 2b: COVID-19 Vaccine Alone, >=65 Years | Group 3b: SIV Alone, >=65 Years | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized 18-64 years | 244900 Participants | 143743 Participants | 843860 Participants | 0 Participants | 0 Participants | 0 Participants | 1232503 Participants |
| Age, Customized 65 years and above | 0 Participants | 0 Participants | 0 Participants | 382835 Participants | 225680 Participants | 1601978 Participants | 2210493 Participants |
| Race/Ethnicity, Customized Data not available | 244900 Participants | 143743 Participants | 843860 Participants | 382835 Participants | 225680 Participants | 1601978 Participants | 3442996 Participants |
| Sex/Gender, Customized Female | 127108 Participants | 78029 Participants | 477067 Participants | 208166 Participants | 132345 Participants | 939216 Participants | 1961931 Participants |
| Sex/Gender, Customized Male | 117692 Participants | 65655 Participants | 366067 Participants | 174651 Participants | 93327 Participants | 661737 Participants | 1479129 Participants |
| Sex/Gender, Customized Unknown | 100 Participants | 59 Participants | 726 Participants | 18 Participants | 8 Participants | 1025 Participants | 1936 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 110 / 244,900 | 63 / 143,743 | 794 / 843,860 | 2,160 / 382,835 | 1,402 / 225,680 | 12,031 / 1,601,978 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 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)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old | 1838 Participants |
| Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years | Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old | 705 Participants |
| Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old | 1837 Participants |
| Group 3a, Model 2: SIV Alone, 18-64 Years | Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old | 12715 Participants |
Comparison: 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.95% CI: [1.018, 1.205]
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [0.606, 0.664]
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.
Time frame: 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)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With All Cause Hospitalization Visits: >=65 Years Old | 7753 Participants |
| Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years | Number of Participants With All Cause Hospitalization Visits: >=65 Years Old | 2719 Participants |
| Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With All Cause Hospitalization Visits: >=65 Years Old | 7751 Participants |
| Group 3a, Model 2: SIV Alone, 18-64 Years | Number of Participants With All Cause Hospitalization Visits: >=65 Years Old | 33926 Participants |
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [1.016, 1.107]
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [0.875, 0.919]
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.
Time frame: 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)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus COVID-19 Alone | 181 Participants |
| Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years | Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus COVID-19 Alone | 55 Participants |
| Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus COVID-19 Alone | 2085 Participants |
| Group 3a, Model 2: SIV Alone, 18-64 Years | Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus COVID-19 Alone | 684 Participants |
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [1.133, 2.1]
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [1.014, 1.206]
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.
Time frame: 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)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone | 145 Participants |
| Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years | Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone | 770 Participants |
| Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone | 953 Participants |
| Group 3a, Model 2: SIV Alone, 18-64 Years | Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone | 3936 Participants |
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [0.903, 1.217]
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [0.846, 0.973]
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.
Time frame: 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)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus COVID-19 Alone | 127 Participants |
| Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years | Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus COVID-19 Alone | 41 Participants |
| Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus COVID-19 Alone | 1674 Participants |
| Group 3a, Model 2: SIV Alone, 18-64 Years | Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus COVID-19 Alone | 535 Participants |
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [1.088, 2.264]
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [1.015, 1.233]
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.
Time frame: 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)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus COVID-19 Alone | 57 Participants |
| Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years | Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus COVID-19 Alone | 14 Participants |
| Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus COVID-19 Alone | 452 Participants |
| Group 3a, Model 2: SIV Alone, 18-64 Years | Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus COVID-19 Alone | 164 Participants |
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [0.88, 2.731]
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [0.865, 1.238]
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.
Time frame: 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)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus COVID-19 Alone | 3513 Participants |
| Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years | Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus COVID-19 Alone | 1399 Participants |
| Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus COVID-19 Alone | 6473 Participants |
| Group 3a, Model 2: SIV Alone, 18-64 Years | Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus COVID-19 Alone | 2268 Participants |
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [1.068, 1.211]
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [1.007, 1.11]
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.
Time frame: 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)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus SIV Alone | 100 Participants |
| Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years | Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus SIV Alone | 558 Participants |
| Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus SIV Alone | 736 Participants |
| Group 3a, Model 2: SIV Alone, 18-64 Years | Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus SIV Alone | 2870 Participants |
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [0.911, 1.286]
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [0.859, 1.01]
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.
Time frame: 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)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus SIV Alone | 47 Participants |
| Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years | Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus SIV Alone | 228 Participants |
| Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus SIV Alone | 232 Participants |
| Group 3a, Model 2: SIV Alone, 18-64 Years | Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus SIV Alone | 1164 Participants |
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [0.687, 1.233]
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [0.722, 0.945]
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.
Time frame: 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)
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus SIV Alone | 1346 Participants |
| Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years | Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus SIV Alone | 6200 Participants |
| Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years | Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus SIV Alone | 1457 Participants |
| Group 3a, Model 2: SIV Alone, 18-64 Years | Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus SIV Alone | 6396 Participants |
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [0.718, 0.807]
Comparison: To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.95% CI: [0.811, 0.907]