Trial Outcomes & Findings for 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. (NCT NCT05858450)
NCT ID: NCT05858450
Last Updated: 2024-09-20
Results Overview
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.
COMPLETED
3442996 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)
2024-09-20
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
244900
|
143743
|
843860
|
382835
|
225680
|
1601978
|
|
Overall Study
COMPLETED
|
244900
|
143743
|
843860
|
382835
|
225680
|
1601978
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Group 1a: Same Day COVID-19 Vaccine and SIV, 18-64 Years
n=244900 Participants
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.
|
Group 2a: COVID-19 Vaccine Alone, 18-64 Years
n=143743 Participants
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.
|
Group 3a: SIV Alone, 18-64 Years
n=843860 Participants
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.
|
Group 1b: Same Day COVID-19 Vaccine and SIV, >= 65 Years
n=382835 Participants
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.
|
Group 2b: COVID-19 Vaccine Alone, >=65 Years
n=225680 Participants
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.
|
Group 3b: SIV Alone, >=65 Years
n=1601978 Participants
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.
|
Total
n=3442996 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
18-64 years
|
244900 Participants
n=5 Participants
|
143743 Participants
n=7 Participants
|
843860 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1232503 Participants
n=8 Participants
|
|
Age, Customized
65 years and above
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
382835 Participants
n=4 Participants
|
225680 Participants
n=21 Participants
|
1601978 Participants
n=8 Participants
|
2210493 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Female
|
127108 Participants
n=5 Participants
|
78029 Participants
n=7 Participants
|
477067 Participants
n=5 Participants
|
208166 Participants
n=4 Participants
|
132345 Participants
n=21 Participants
|
939216 Participants
n=8 Participants
|
1961931 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Male
|
117692 Participants
n=5 Participants
|
65655 Participants
n=7 Participants
|
366067 Participants
n=5 Participants
|
174651 Participants
n=4 Participants
|
93327 Participants
n=21 Participants
|
661737 Participants
n=8 Participants
|
1479129 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Unknown
|
100 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
726 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
1025 Participants
n=8 Participants
|
1936 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Data not available
|
244900 Participants
n=5 Participants
|
143743 Participants
n=7 Participants
|
843860 Participants
n=5 Participants
|
382835 Participants
n=4 Participants
|
225680 Participants
n=21 Participants
|
1601978 Participants
n=8 Participants
|
3442996 Participants
n=8 Participants
|
PRIMARY outcome
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)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).
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.
Outcome measures
| Measure |
Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=244900 Participants
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.
|
Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years
n=143743 Participants
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.
|
Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=244820 Participants
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.
|
Group 3a, Model 2: SIV Alone, 18-64 Years
n=843412 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old
|
1838 Participants
|
705 Participants
|
1837 Participants
|
12715 Participants
|
PRIMARY outcome
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)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).
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.
Outcome measures
| Measure |
Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=382835 Participants
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.
|
Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years
n=225680 Participants
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.
|
Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=382626 Participants
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.
|
Group 3a, Model 2: SIV Alone, 18-64 Years
n=1600981 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With All Cause Hospitalization Visits: >=65 Years Old
|
7753 Participants
|
2719 Participants
|
7751 Participants
|
33926 Participants
|
PRIMARY outcome
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)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).
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.
Outcome measures
| Measure |
Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=244900 Participants
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.
|
Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years
n=143743 Participants
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.
|
Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=382835 Participants
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.
|
Group 3a, Model 2: SIV Alone, 18-64 Years
n=225680 Participants
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.
|
|---|---|---|---|---|
|
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
|
55 Participants
|
2085 Participants
|
684 Participants
|
PRIMARY outcome
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)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).
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.
Outcome measures
| Measure |
Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=244820 Participants
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.
|
Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years
n=843412 Participants
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.
|
Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=382626 Participants
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.
|
Group 3a, Model 2: SIV Alone, 18-64 Years
n=1600981 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone
|
145 Participants
|
770 Participants
|
953 Participants
|
3936 Participants
|
PRIMARY outcome
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)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).
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.
Outcome measures
| Measure |
Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=244900 Participants
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.
|
Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years
n=143743 Participants
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.
|
Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=382835 Participants
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.
|
Group 3a, Model 2: SIV Alone, 18-64 Years
n=225680 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus COVID-19 Alone
|
3513 Participants
|
1399 Participants
|
6473 Participants
|
2268 Participants
|
PRIMARY outcome
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)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).
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.
Outcome measures
| Measure |
Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=244820 Participants
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.
|
Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years
n=843412 Participants
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.
|
Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=382626 Participants
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.
|
Group 3a, Model 2: SIV Alone, 18-64 Years
n=1600981 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus SIV Alone
|
1346 Participants
|
6200 Participants
|
1457 Participants
|
6396 Participants
|
PRIMARY outcome
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)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).
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.
Outcome measures
| Measure |
Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=244900 Participants
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.
|
Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years
n=143743 Participants
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.
|
Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=382835 Participants
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.
|
Group 3a, Model 2: SIV Alone, 18-64 Years
n=225680 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus COVID-19 Alone
|
57 Participants
|
14 Participants
|
452 Participants
|
164 Participants
|
PRIMARY outcome
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)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).
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.
Outcome measures
| Measure |
Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=244820 Participants
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.
|
Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years
n=843412 Participants
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.
|
Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=382626 Participants
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.
|
Group 3a, Model 2: SIV Alone, 18-64 Years
n=1600981 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus SIV Alone
|
47 Participants
|
228 Participants
|
232 Participants
|
1164 Participants
|
PRIMARY outcome
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)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).
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.
Outcome measures
| Measure |
Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=244900 Participants
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.
|
Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years
n=143743 Participants
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.
|
Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=382835 Participants
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.
|
Group 3a, Model 2: SIV Alone, 18-64 Years
n=225680 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus COVID-19 Alone
|
127 Participants
|
41 Participants
|
1674 Participants
|
535 Participants
|
PRIMARY outcome
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)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).
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.
Outcome measures
| Measure |
Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=244820 Participants
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.
|
Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years
n=843412 Participants
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.
|
Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years
n=382626 Participants
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.
|
Group 3a, Model 2: SIV Alone, 18-64 Years
n=1600981 Participants
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.
|
|---|---|---|---|---|
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Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus SIV Alone
|
100 Participants
|
558 Participants
|
736 Participants
|
2870 Participants
|
Adverse Events
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
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER