Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data
NCT ID: NCT06199934
Last Updated: 2025-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
19853610 participants
OBSERVATIONAL
2023-09-11
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Vaccinated
BNT162b2 recipients
Vaccination
BNT162b2 vaccination
Unvaccinated
BNT162b2 eligible but did not receive
No interventions assigned to this group
Interventions
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Vaccination
BNT162b2 vaccination
Eligibility Criteria
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Inclusion Criteria
* State of California or Louisiana resident for at least one year
Exclusion Criteria
* 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.
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Global Headquarters
New York, New York, United States
Countries
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References
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Andersen KM, McColgan MD, Mateus JS, Yu T, Zhou A, Puzniak L, Lopez SMC. BNT162b2 XBB.1.5-Adapted Single Dose Vaccine Uptake and Effectiveness in Children Aged 5-17 Years Using Linked Claims and Vaccine Registries in California and Louisiana. J Pediatr. 2025 Nov;286:114778. doi: 10.1016/j.jpeds.2025.114778. Epub 2025 Aug 14.
Andersen KM, Allen KE, Nepal RM, Mateus JS, Yu T, Zhou A, Porter TM, Lopez SMC, Puzniak L, McLaughlin JM, McGrath LJ. Effectiveness of BNT162b2 XBB.1.5 vaccine in immunocompetent adults using tokenization in two U.S. states. Vaccine. 2025 Apr 11;52:126881. doi: 10.1016/j.vaccine.2025.126881. Epub 2025 Feb 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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RAVEN
Identifier Type: OTHER
Identifier Source: secondary_id
C4591065
Identifier Type: -
Identifier Source: org_study_id
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