Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data (NCT05876377) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data
United States1 participantsStarted 2023-10-23
Plain-language summary
This study aims to use vaccination information from state vaccine registries linked with HealthVerity insurance claims for the following:
* to measure how effective the Pfizer-BioNTech vaccine is at preventing post-COVID conditions.
* to understand characteristics of patients who are receiving COVID-19 vaccines.
All patients whose information is kept unidentified in the HealthVerity database are eligible to be included for both aims of this study.
Who can participate
Age range6 Months
SexALL
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Inclusion criteria
✓. Patients are required to have a COVID-19 diagnosis on or after September 5, 2024 AND no later than August 26, 2025
✓. Patients in HealthVerity database and residing in California or Louisiana as of index date AND
✓. Have ≥1 year of pharmacy and medical enrollment in HealthVerity prior to cohort entry date, allowing for up to a 30-day gap in enrollment AND
✓. ≥18 years old as of index date AND
✓. Have resided only in their respective state (California or Louisiana) for ≥1 year prior to index date
Exclusion criteria
✕. Patients who were immunocompromised from 1 year prior to cohort entry OR
✕. Patients who received any 2024-2025 formulation of the COVID-19 vaccine prior to authorization (22 August 2024) OR
✕. Patients who have discrepancies in sex and/or year of birth between HealthVerity claims and state immunization registry datasets OR
✕. Patients who had a prior diagnosis of COVID-19 ≤180 days preceding cohort entry OR
✕. Patients who received any 2024/2025 formulation of the COVID-19 vaccine within 0 to 13 days prior OR 0 to 29 days post index COVID-19 diagnosis (i.e., -13 to +29 days around the index date)
✕. Has medical and pharmacy enrollment in HealthVerity as of August 31, 2022
What they're measuring
1
Aim 1: Any PCC-related diagnosis not present before the COVID-19 diagnosis
Timeframe: 30-180 days after COVID-19 diagnosis
2
Aim 2: Number of patients with a COVID-19 vaccination
Timeframe: Date of vaccine authorization through the end of the corresponding respiratory season