Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data

Active, not recruiting

• Conditions: SARS-CoV-2; COVID-19 Vaccines
• Interventions: Biological: Vaccination

• Registration Number: NCT06199934
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-10
• Status Verified: 2024-02
• Study Start: 2024-02-07
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaccinated	Vaccination	BNT162b2 recipients

Primary Outcome Measures

Name	Time	Method
Number of people with a COVID-19-related encounter, regardless of setting	6 months

Secondary Outcome Measures

Name	Time	Method
Number of people with COVID-19-related hospitalization	9 months
Number of people with inpatient mortality	4 months
Number of people with an outpatient encounter with ICD-10-CM U07.1 "COVID-19" code	6 months
Number of people with negative control outcomes	6 months
All-cause healthcare mean costs will be assessed using the cost data from administrative healthcare claims dataset	9 months
Number of people with non-COVID-19 respiratory infection	6 months
Number of people who received antiviral treatment	4 months
COVID-19 hospitalization mean costs will be assessed using the total cost data from administrative healthcare claims dataset	4 months
Number of people who received high-flow oxygen or mechanical ventilation	4 months
All-cause healthcare resource utilization as the total number of encounters, regardless of setting, using data from administrative healthcare claims dataset	9 months
Number of people with an inpatient encounter with ICD-10-CM U07.1 "COVID-19" code	6 months
Number of people with an emergency department encounter with ICD-10-CM U07.1 "COVID-19" code	6 months
Number of people with COVID-19 critical illness	6 months
Average length of stay, in days	4 months
Number of people who had ICU admission	4 months

Trial Locations

Locations (1)

Pfizer Global Headquarters; 🇺🇸 New York, New York, United States