Clinical trial NCT05858450: 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.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza, Human
COVID-19
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-05-15
Enrollment: 3442996
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adults patients who were enrolled in the Optum Clinformatics Database as of 31 August 2022

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.


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).

Primary outcomes:
measure: Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old
timeFrame: 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)
measure: Number of Participants With All Cause Hospitalization Visits: >=65 Years Old
timeFrame: 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)
measure: Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus COVID-19 Alone
timeFrame: 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)
measure: Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone
timeFrame: 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)
measure: Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus COVID-19 Alone
timeFrame: 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)
measure: Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus SIV Alone
timeFrame: 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)
measure: Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus COVID-19 Alone
timeFrame: 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)
measure: Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus SIV Alone
timeFrame: 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)
measure: Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus COVID-19 Alone
timeFrame: 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)
measure: Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus SIV Alone
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: