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

SARS-CoV-2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06199934
• Other study ID #: C4591065
• Secondary ID: RAVEN
• Status: Active, not recruiting
• Start date: February 7, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Vaccines
• SARS-CoV-2

Intervention

Biological:
• Vaccination
BNT162b2 vaccination

Locations

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

External Links

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