SARS-CoV-2NCT06199934
Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data
An observational study of SARS-CoV-2 and COVID-19 Vaccines, run by Pfizer at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SARS-CoV-2, COVID-19 Vaccines
- What is being tested?
- Vaccination
- Type of treatment
- Vaccines
- How many people
- 19,853,610 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were California or Louisiana residents in the HealthVerity claims database will be defined using the following hierarchical definition: 1. Persons who have their enrollment file record indicating a patient location of California or Louisiana in HealthVerity claims enrollment file. 2. Persons who have a patient state location other than California or Louisiana in HealthVerity claims enrollment but have one or more records in the California or Louisiana Immunization Registry. Examples include people who previously lived in Texas but moved to California and received a vaccine, or persons who crossed state lines for a vaccine and remain in their non-California state in claims data.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Global Headquarters
New York, New York, 10001
About this study
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.
- Conditions
- SARS-CoV-2, COVID-19 Vaccines
- Being tested
- Vaccination
- Keywords
- COVID-19, XBB vaccine effectiveness
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccinationBiological
BNT162b2 vaccination
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated | BNT162b2 recipients Receives: Biological: Vaccination | |
| Unvaccinated | BNT162b2 eligible but did not receive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants COVID-19 Diagnosis
Number of participants diagnosed with COVID-19 were reported in this outcome measure.
Measured: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
Secondary outcomes (15)
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.
Measured: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
Number of Participants With an Inpatient Encounter
Inpatient encounter was considered as an encounter with ICD-10-CM code: U07.1.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Number of Participants With Inpatient Mortality
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start11 Sep 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19,853,610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199934
- Sponsor's protocol ID
- C4591065
- Other IDs
- RAVEN
- Status last verified
- Aug 2025
- First submitted
- 18 Dec 2023
- Last updated
- 10 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 40818804Andersen 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.
PubMed 39987879
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data
- ClinicalTrials.gov ID
- NCT06199934
- Acronym / sponsor ID
- C4591065
- Conditions
- SARS-CoV-2, COVID-19 Vaccines
- Keywords
- COVID-19, XBB vaccine effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,853,610 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Posted 10 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated | – | Biological: VaccinationBNT162b2 recipients |
| Unvaccinated | – | –BNT162b2 eligible but did not receive |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were California or Louisiana residents in the HealthVerity claims database will be defined using the following hierarchical definition: 1. Persons who have their enrollment file record indicating a patient location of California or Louisiana in HealthVerity claims enrollment file. 2. Persons who have a patient state location other than California or Louisiana in HealthVerity claims enrollment but have one or more records in the California or Louisiana Immunization Registry. Examples include people who previously lived in Texas but moved to California and received a vaccine, or persons who crossed state lines for a vaccine and remain in their non-California state in claims data.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VaccinationBNT162b2 vaccination | Biological | Vaccinated |
Primary outcome
Number of Participants COVID-19 Diagnosis
Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
Number of participants diagnosed with COVID-19 were reported in this outcome measure.
15 secondary outcomes
Number of Participants With an Outpatient Encounter
Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
Number of Participants With an Inpatient Encounter
Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
Number of Participants With Emergency Department Encounter
Time frame: 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
Time frame: 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
Time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)
Number of Participants With Negative Control Outcomes
Time frame: 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
Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Average Length of Stay (LOS)
Time frame: 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.
Time frame: 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)
Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Number of Participants With Inpatient Mortality
Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Number of Participants Who Received Antiviral Treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From 1 month after index date (hospitalization date) until end of follow-up (Up to 4 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40818804Andersen 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.
- Derived from this study: PubMed 39987879Andersen 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and COVID-19 Vaccines, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants COVID-19 Diagnosis (time frame: From date of FDA authorization/approval of BNT162b2 until end of follow-up (maximum of 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06199934, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.