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| ID | Type | Description | Link |
|---|---|---|---|
| RAVEN | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccinated | BNT162b2 recipients |
| |
| Unvaccinated | BNT162b2 eligible but did not receive |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccination | Biological | BNT162b2 vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants COVID-19 Diagnosis | Number of participants diagnosed with COVID-19 were reported in this outcome measure. | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Outpatient Encounter | Outpatient encounter was considered as an encounter with International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code: U07.1. | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) |
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Inclusion Criteria:
Exclusion criteria:
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Patients who were California or Louisiana residents in the HealthVerity claims database will be defined using the following hierarchical definition:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Global Headquarters | New York | New York | 10001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40818804 | Derived | 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. | |
| 39987879 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 19853610 participants were enrolled this study.
Data from adult and pediatric participants who were residents of California or Louisiana were collected from immunization registry linked to closed claims from HealthVerity in this retrospective study. Data was collected from HealthVerity Database from 11-Sep-2023 to 12-Mar-2024, available data was evaluated from 07-Feb-2024 to 31-Jul-2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all eligible participants whose data were retrieved and observed in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Here "Number Analyzed" signifies number of participants evaluable for this baseline characteristic. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants COVID-19 Diagnosis | Number of participants diagnosed with COVID-19 were reported in this outcome measure. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) |
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|
Adverse events and death were not collected; hence, time frame was not applicable
In this observational retrospective study of deidentified database individual identifying information was not available. Minimum criteria for reporting an adverse event could not be met, hence SAEs and other AEs were not planned to be collected and reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Adult and pediatric participants data were collected from immunization registry linked to closed claims from HealthVerity and who were California or Louisiana residents were included. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 18007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2023 | Jul 31, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 11, 2024 | Jul 31, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014611 | Vaccination |
| ID | Term |
|---|---|
| D016233 | Immunotherapy, Active |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
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| Number of Participants With an Inpatient Encounter |
Inpatient encounter was considered as an encounter with ICD-10-CM code: U07.1. |
| From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) |
| Number of Participants With Emergency Department Encounter | Number of emergency department encounter was considered as an encounter with ICD-10-CM code: U07.1. | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) |
| Number of Participants With COVID-19 Critical Illness | COVID-19 critical illness was defined as intensive care unit [ICU] admission, mechanical ventilation, or inpatient death. | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) |
| Number of Participants With Non-COVID-19 Respiratory Infection | Non-COVID-19 respiratory infection included: diagnosis of any of pneumonia, respiratory syncytial virus (RSV), rhinovirus and/or receipt of antibiotic prescription. | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) |
| Number of Participants With Negative Control Outcomes | Negative outcomes included: accidental injury, ingrown toenail and atopic dermatitis. Number of participants with any negative control outcomes were reported in this outcome measure. | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) |
| Total Costs of All-cause Hospitalizations From Administrative Healthcare Claims Dataset | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
| Average Length of Stay (LOS) | Average length of stay was defined as date of service end minus date of service start. | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
| Number of Participants With ICU Admission Are Included in This Outcome Measure. | Percentage of participants with ICU admission within 30 Days of follow-up are included in this outcome measure. | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
| Number of Participants Who Received High-flow Oxygen or Mechanical Ventilation (MV) | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
| Number of Participants With Inpatient Mortality | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
| Number of Participants Who Received Antiviral Treatment | Number of participants who received antiviral COVID treatment is reported. | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
| Mean Cost of All-cause Healthcare From Administrative Healthcare Claims Dataset | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
| All-cause Healthcare Resource Utilization as The Total Number of Encounters, Regardless of Setting, Using Data From Administrative Healthcare Claims Dataset | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
| Number of Participants With COVID-19-Related Hospitalization | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
| 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. |
| Mean |
| Standard Deviation |
| Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Participants |
|
|
| Secondary | Number of Participants With an Outpatient Encounter | Outpatient encounter was considered as an encounter with International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code: U07.1. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) |
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|
|
| Secondary | Number of Participants With an Inpatient Encounter | Inpatient encounter was considered as an encounter with ICD-10-CM code: U07.1. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) |
|
|
|
| Secondary | Number of Participants With Emergency Department Encounter | Number of emergency department encounter was considered as an encounter with ICD-10-CM code: U07.1. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) |
|
|
|
| Secondary | Number of Participants With COVID-19 Critical Illness | COVID-19 critical illness was defined as intensive care unit [ICU] admission, mechanical ventilation, or inpatient death. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) |
|
|
|
| Secondary | Number of Participants With Non-COVID-19 Respiratory Infection | Non-COVID-19 respiratory infection included: diagnosis of any of pneumonia, respiratory syncytial virus (RSV), rhinovirus and/or receipt of antibiotic prescription. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) |
|
|
|
| Secondary | Number of Participants With Negative Control Outcomes | Negative outcomes included: accidental injury, ingrown toenail and atopic dermatitis. Number of participants with any negative control outcomes were reported in this outcome measure. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months) |
|
|
|
| Secondary | Total Costs of All-cause Hospitalizations From Administrative Healthcare Claims Dataset | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Mean | Standard Deviation | US Dollars | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
|
|
|
| Secondary | Average Length of Stay (LOS) | Average length of stay was defined as date of service end minus date of service start. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Mean | Standard Deviation | Days | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
|
|
|
| Secondary | Number of Participants With ICU Admission Are Included in This Outcome Measure. | Percentage of participants with ICU admission within 30 Days of follow-up are included in this outcome measure. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
|
|
|
| Secondary | Number of Participants Who Received High-flow Oxygen or Mechanical Ventilation (MV) | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
|
|
|
| Secondary | Number of Participants With Inpatient Mortality | Data was not collected for this outcome measure as mortality information in the HealthVerity data was delayed several months behind real time, to protect confidentiality, and were not available at the time of analyses for the study period. | Posted | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
|
|
| Secondary | Number of Participants Who Received Antiviral Treatment | Number of participants who received antiviral COVID treatment is reported. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
|
|
|
| Secondary | Mean Cost of All-cause Healthcare From Administrative Healthcare Claims Dataset | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Mean | Standard Deviation | US Dollars | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
|
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|
| Secondary | All-cause Healthcare Resource Utilization as The Total Number of Encounters, Regardless of Setting, Using Data From Administrative Healthcare Claims Dataset | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Mean | Standard Deviation | Encounters | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
|
|
|
| Secondary | Number of Participants With COVID-19-Related Hospitalization | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001691 |
| Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |