Clinical trial NCT06199934: Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data
Official title: Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
COVID-19 Vaccines
Keywords: COVID-19
XBB vaccine effectiveness
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-01-10
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were California or Louisiana residents in the HealthVerity claims database will be defined using the following hierarchical definition:

1. Persons who have their enrollment file record indicating a patient location of California or Louisiana in HealthVerity claims enrollment file.
2. Persons who have a patient state location other than California or Louisiana in HealthVerity claims enrollment but have one or more records in the California or Louisiana Immunization Registry. Examples include people who previously lived in Texas but moved to California and received a vaccine, or persons who crossed state lines for a vaccine and remain in their non-California state in claims data.

Brief summary: The primary purpose of this study is to learn about how well different versions of the Pfizer-BioNTech COVID-19 vaccine (called BNT162b2) work at preventing death, severe COVID-19 that requires a trip to the hospital, and overall use of healthcare resources, such as needing to go the doctor or urgent care due to illness. Pfizer is not enrolling any participants for this study. Instead, existing data from different health data sources will be used to help answer the scientific questions Pfizer is interested in learning more about.


Eligibility criteria: Inclusion Criteria:

* People with at least one year of pharmacy and medical enrollment in HealthVerity prior to vaccine availability
* State of California or Louisiana resident for at least one year

Exclusion criteria:

* People currently pregnant,
* Individuals with discrepancies in sex and/or year of birth between HealthVerity claims and California/Louisiana immunization registry datasets
* A diagnosis of COVID-19 in any setting ≤ 90 days prior to start of study or receipt COVID-19 vaccine ≤ 90 days prior to start of study.

Primary outcomes:
measure: Number of people with a COVID-19-related encounter, regardless of setting
timeFrame: 6 months
Secondary outcomes:
measure: Number of people with an outpatient encounter with ICD-10-CM U07.1 "COVID-19" code
timeFrame: 6 months
measure: Number of people with an inpatient encounter with ICD-10-CM U07.1 "COVID-19" code
timeFrame: 6 months
measure: Number of people with an emergency department encounter with ICD-10-CM U07.1 "COVID-19" code
timeFrame: 6 months
measure: Number of people with COVID-19 critical illness
timeFrame: 6 months
measure: Number of people with non-COVID-19 respiratory infection
timeFrame: 6 months
measure: Number of people with negative control outcomes
timeFrame: 6 months
measure: COVID-19 hospitalization mean costs will be assessed using the total cost data from administrative healthcare claims dataset
timeFrame: 4 months
measure: Average length of stay, in days
timeFrame: 4 months
measure: Number of people who had ICU admission
timeFrame: 4 months
measure: Number of people who received high-flow oxygen or mechanical ventilation
timeFrame: 4 months
measure: Number of people with inpatient mortality
timeFrame: 4 months
measure: Number of people who received antiviral treatment
timeFrame: 4 months
measure: All-cause healthcare mean costs will be assessed using the cost data from administrative healthcare claims dataset
timeFrame: 9 months
measure: All-cause healthcare resource utilization as the total number of encounters, regardless of setting, using data from administrative healthcare claims dataset
timeFrame: 9 months
measure: Number of people with COVID-19-related hospitalization
timeFrame: 9 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer Global Headquarters
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: