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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06199934
Other study ID # C4591065
Secondary ID RAVEN
Status Active, not recruiting
Phase
First received
Last updated
Start date February 7, 2024
Est. completion date July 31, 2024

Study information

Verified date February 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
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 July 31, 2024
Est. primary completion date July 31, 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.

Study Design


Related Conditions & MeSH terms


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
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