Status:
ACTIVE_NOT_RECRUITING
A Study to Learn About How Well Yearly Updates to the COVID-19 Vaccine Work to Protect People From COVID-19 and How Much Money People Spend on Healthcare for COVID-19
Lead Sponsor:
Pfizer
Conditions:
COVID-19 SARS-CoV-2 Infection
COVID-19
Eligibility:
All Genders
6+ years
Brief Summary
The purpose of this study is to learn about how well the yearly updates to the COVID-19 vaccine work in adults (age 18 years and above) with a healthy immune system (the body's cells, tissues and orga...
Detailed Description
Rationale and Background On April 6, 2022, members of the United States (US) Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the Food and Drug Administration (FDA) voted for t...
Eligibility Criteria
Inclusion
- The youngest possible age for any person in any aim of the study is 6 months old.
- For objectives pertaining to adults, this protocol will be conducted among persons who have all of the following:
- At least one year of continuous medical enrollment prior to index date in an insurance plan that contributes to the HealthVerity claims database in the United States. Medical claims are used to measure inpatient, outpatient, emergency department and urgent care encounters. A gap of up to 30 days will be allowed.
- At least one year of continuous pharmacy enrollment prior to index date in an insurance plan that contributes to the HealthVerity claims database in the United States. Pharmacy claims are used to measure outpatient dispensations of drugs, vaccines, and other biological products. A gap of up to 30 days will be allowed.
- At least one year of continuous state residency in a state with mandatory COVID-19 vaccination reporting that contributes the entire state vaccine registry to HealthVerity.
- Does not have discrepancies in sex and/or year of birth between any of the available datasets. These are critical covariates in models as they are amongst the most important risk factors for severe disease.
- Did not have documented episode of COVID-19 and/or receipt of any COVID-19 vaccine during the 90 days prior to index date. These persons likely have lower risk of vaccination (the study's exposure of interest) as well as temporarily lower risk of COVID-19 (the study's outcome of interest), which would introduce heterogeneity in estimates were they not excluded.
- For objectives pertaining to pediatrics, this protocol will be conducted among persons who have all of the following:
- At least six months of continuous medical enrollment prior to index date in an insurance plan that contributes to the HealthVerity claims database in the United States. Medical claims are used to measure inpatient, outpatient, emergency department and urgent care encounters. A gap of up to 30 days will be allowed.
- At least six months of continuous pharmacy enrollment prior to index date in an insurance plan that contributes to the HealthVerity claims database in the United States. Pharmacy claims are used to measure outpatient dispensations of drugs, vaccines, and other biological products. A gap of up to 30 days will be allowed.
- At least six months of continuous state residency in a state with mandatory COVID-19 vaccination reporting that contributes the entire state vaccine registry to HealthVerity.
- Does not have discrepancies in sex and/or year of birth between any of the available datasets. These are critical covariates in models as they are amongst the most important risk factors for severe disease.
- Did not have documented episode of COVID-19 and/or receipt of any COVID-19 vaccine during the 90 days prior to index date. These persons likely have lower risk of vaccination (the study's exposure of interest) as well as temporarily lower risk of COVID-19 (the study's outcome of interest), which would introduce heterogeneity in estimates were they not excluded.
Exclusion
Key Trial Info
Start Date :
April 16 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2030
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT06923137
Start Date
April 16 2025
End Date
October 31 2030
Last Update
November 19 2025
Active Locations (1)
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1
Pfizer
New York, New York, United States, 10001