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

NCT ID: NCT06199934

Last Updated: 2025-09-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19853610 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-11

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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SARS-CoV-2 COVID-19 Vaccines

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Vaccinated

BNT162b2 recipients

Vaccination

Intervention Type BIOLOGICAL

BNT162b2 vaccination

Unvaccinated

BNT162b2 eligible but did not receive

No interventions assigned to this group

Interventions

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Vaccination

BNT162b2 vaccination

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 40818804 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39987879 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4591065

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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