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.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Same day Pfizer-BioNTech mRNA bivalent COVID and flu on the same day |
Biological: Comirnaty
COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
Biological: Quadrivalent 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
|
| COVID alone Pfizer-BioNTech bivalent COVID only |
Biological: Comirnaty
COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
|
| flu alone influenza vaccine of any type only |
Biological: Quadrivalent 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
|
Outcome Measures
Primary Outcome Measures
- Number of COVID-related hospitalization/emergency department visit/urgent care visit [Baseline - greater than 14 days after index vaccination]
An acute inpatient admission or an emergency department/urgent care claim with a diagnosis of COVID-19 in any coding position
- Number of COVID-related outpatient visit (excluding ER/urgent care) [Baseline - greater than 14 days after index vaccination]
An outpatient claim with a diagnosis of COVID-19 in any coding position, excluding visits with an ER/urgent care place of service code
- Number of Influenza-related hospitalization/emergency department visit/urgent care visit [Baseline - greater than 14 days after index vaccination]
An acute inpatient admission or an emergency department/urgent care claim with a diagnosis of influenza in any coding position
- Number of Influenza-related outpatient visit (excluding ER/urgent care) [Baseline - greater than 14 days after index vaccination]
An outpatient claim with a diagnosis of influenza in any coding position, excluding visits with an ER/urgent care place of service code
- Number of All-cause hospitalization [Baseline - greater than 14 days after index vaccination]
An acute inpatient admission for any cause
- Number of COVID-related hospitalization [Baseline - greater than 14 days after index vaccination]
An acute inpatient admission with a diagnosis of COVID-19 in any coding position
- Number of COVID-related emergency department visit/urgent care visit [Baseline - greater than 14 days after index vaccination]
An emergency department/urgent care claim with a diagnosis of COVID-19 in any coding position
- Number of Influenza-related hospitalization [Baseline - greater than 14 days after index vaccination]
An acute inpatient admission with a diagnosis of influenza in any coding position
- Number of Influenza-related emergency department visit/urgent care visit [Baseline - greater than 14 days after index vaccination]
An emergency department/urgent care claim with a diagnosis of influenza in any coding position
Eligibility Criteria
Criteria
Inclusion Criteria:
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Enrolled in Optum claims database as of 31 August 2022 (date bivalent authorized).
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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).
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Aged >=18 years on the index date
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365 days of continuous enrolment prior to index date
Exclusion Criteria:
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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.
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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.
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Has influenza vaccine between 01 August -30 August 2022 (before study period).
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Has a COVID-19 or influenza diagnosis code in any setting within 14 days after index vaccination (excluded from all cohorts).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer | New York | New York | United States | 10001 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C4591061