Clinical trial
Investigating Uptake and Subsequent Health Outcomes Associated With Pfizer-BioNTech Bivalent COVID-19/Influenza Vaccine Concomitant Administration Using a Claims-based Real-world Data Source in the US
Name
C4591061
Description
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.
Trial arms
Trial start
2023-05-05
Estimated PCD
2023-05-12
Trial end
2023-05-12
Status
Completed
Treatment
Comirnaty
COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
Arms:
COVID alone, Same day
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
Arms:
Same day, flu alone
Size
1
Primary endpoint
Number of COVID-related hospitalization/emergency department visit/urgent care visit
Baseline - greater than 14 days after index vaccination
Number of COVID-related outpatient visit (excluding ER/urgent care)
Baseline - greater than 14 days after index vaccination
Number of Influenza-related hospitalization/emergency department visit/urgent care visit
Baseline - greater than 14 days after index vaccination
Number of Influenza-related outpatient visit (excluding ER/urgent care)
Baseline - greater than 14 days after index vaccination
Number of All-cause hospitalization
Baseline - greater than 14 days after index vaccination
Number of COVID-related hospitalization
Baseline - greater than 14 days after index vaccination
Number of COVID-related emergency department visit/urgent care visit
Baseline - greater than 14 days after index vaccination
Number of Influenza-related hospitalization
Baseline - greater than 14 days after index vaccination
Number of Influenza-related emergency department visit/urgent care visit
Baseline - greater than 14 days after index vaccination
Eligibility criteria
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).
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}
Updated at
2023-06-01
1 organization
2 products
3 indications
Organization
PfizerProduct
ComirnatyIndication
InfluenzaIndication
HumanIndication
COVID-19