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.
- Conditions
- Influenza, HumanCOVID-19
- Interventions
- Registration Number
- NCT05858450
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
- 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
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Same day Comirnaty Pfizer-BioNTech mRNA bivalent COVID and flu on the same day flu alone Quadrivalent Influenza Vaccine influenza vaccine of any type only Same day Quadrivalent Influenza Vaccine Pfizer-BioNTech mRNA bivalent COVID and flu on the same day COVID alone Comirnaty Pfizer-BioNTech bivalent COVID only
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer
🇺🇸New York, New York, United States