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.

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05858450
• Other study ID #: C4591061
• Status: Completed
• Start date: May 5, 2023
• Est. completion date: May 12, 2023

Study information

• Verified date: May 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 12, 2023
• Est. primary completion date: May 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19
• Influenza, Human

Intervention

Biological:
• Comirnaty
COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
• 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

Locations

Country	Name	City	State
United States	Pfizer	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of COVID-related hospitalization/emergency department visit/urgent care visit	An acute inpatient admission or an emergency department/urgent care claim with a diagnosis of COVID-19 in any coding position	Baseline - greater than 14 days after index vaccination
Primary	Number of COVID-related outpatient visit (excluding ER/urgent care)	An outpatient claim with a diagnosis of COVID-19 in any coding position, excluding visits with an ER/urgent care place of service code	Baseline - greater than 14 days after index vaccination
Primary	Number of Influenza-related hospitalization/emergency department visit/urgent care visit	An acute inpatient admission or an emergency department/urgent care claim with a diagnosis of influenza in any coding position	Baseline - greater than 14 days after index vaccination
Primary	Number of Influenza-related outpatient visit (excluding ER/urgent care)	An outpatient claim with a diagnosis of influenza in any coding position, excluding visits with an ER/urgent care place of service code	Baseline - greater than 14 days after index vaccination
Primary	Number of All-cause hospitalization	An acute inpatient admission for any cause	Baseline - greater than 14 days after index vaccination
Primary	Number of COVID-related hospitalization	An acute inpatient admission with a diagnosis of COVID-19 in any coding position	Baseline - greater than 14 days after index vaccination
Primary	Number of COVID-related emergency department visit/urgent care visit	An emergency department/urgent care claim with a diagnosis of COVID-19 in any coding position	Baseline - greater than 14 days after index vaccination
Primary	Number of Influenza-related hospitalization	An acute inpatient admission with a diagnosis of influenza in any coding position	Baseline - greater than 14 days after index vaccination
Primary	Number of Influenza-related emergency department visit/urgent care visit	An emergency department/urgent care claim with a diagnosis of influenza in any coding position	Baseline - greater than 14 days after index vaccination

External Links

•   To obtain contact information for a study center near you, click here.