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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.

Pfizer logo

Pfizer

Status

Completed

Conditions

COVID-19
Influenza, Human

Treatments

Biological: Quadrivalent Influenza Vaccine
Biological: Comirnaty

Study type

Observational

Funder types

Industry

Identifiers

NCT05858450
C4591061

Details and patient eligibility

About

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.

Enrollment

3,442,996 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

3,442,996 participants in 3 patient groups

Same day
Description:
Pfizer-BioNTech mRNA bivalent COVID and flu on the same day
Treatment:
Biological: Comirnaty
Biological: Quadrivalent Influenza Vaccine
COVID alone
Description:
Pfizer-BioNTech bivalent COVID only
Treatment:
Biological: Comirnaty
flu alone
Description:
influenza vaccine of any type only
Treatment:
Biological: Quadrivalent Influenza Vaccine

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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