ImmunocompromisedNCT05020145
COVID-19 Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States
An observational study of Immunocompromised and Immunosuppressed, run by Pfizer at 1 site in United States.
Trial summary
This retrospective study will evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Immunocompromised, Immunosuppressed, Covid-19
- What is being tested?
- BNT162b2 (Tozinameran)
- Type of treatment
- Vaccines
- How many people
- 1,277,747 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2021to 17 Dec 2021
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The main study population consists of subjects >12 that received Covid-19 vaccination, had no evidence of prior infection, had continuous enrollment and evidence of immunocompromising conditions during the baseline pre vaccination period.
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Unique enrollees in the HealthVerity Vaccine dataset anytime after December 10, 2020
- At least 12 years on the index date (ie, first vaccination date)
- No evidence of prior COVID-19 infection (a medical claim, pharmacy claim, or chargemaster record with a diagnosis code of ICD-10-CM U07.1) in the 12 months prior to the index date
- Have 12 months of continuous enrollment with medical benefits (with or without pharmacy benefits) prior to the index date.
- Subjects with an IC condition will be identified via an algorithm developed for use in administrative claims database studies.
- Exclusion criteria: subjects not meeting the criteria above will be excluded.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coronavirus Disease 2019 (COVID-19) Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States
This retrospective study will evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination.
Read the detailed description
The objective of this US-based retrospective cohort study is to evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination.
Subjects will be aged 12 years and older and will have no evidence of prior SARS-CoV-2 infection.
The primary analysis will be conducted on subjects vaccinated with BNT162b2.
A variety of subgroup analyses and sensitivity analyses are planned.
- Conditions
- Immunocompromised, Immunosuppressed, Covid-19, SARS-COV-2, SARS-COV-2 Infection, Breakthrough Infection
- Being tested
- BNT162b2 (Tozinameran)
- Keywords
- Immunocompromised, Immunosuppressed, Immunosuppressive drugs, Covid-19, Covid-19 Vaccination, mRNA Vaccine, SARS-CoV-2 Vaccine, BNT162b2, Breakthrough Infection, SARS-COV-2 Infection, SARS-COV-2
- Medical subject headings
- COVID-19, Breakthrough Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2 (Tozinameran)Biological
Also called Pfizer-BioNTech COVID-19 vaccine
Covid-19 Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Immunocompromised | Vaccinated Subject with 1 or >1 immunocompromising conditions. Receives: Biological: BNT162b2 (Tozinameran) | |
| Non-Immunocompromised | Vaccinated subjects without evidence of immunocompromising condition. Receives: Biological: BNT162b2 (Tozinameran) | |
| Total Population (immunocompromised and non) | Vaccinated Subjects with or without 1 or >1 immunocompromising conditions. Receives: Biological: BNT162b2 (Tozinameran) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Breakthrough Cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
The incidence rate of breakthrough cases of SARS-CoV-2 infection was calculated as the number of participants who experienced the event divided by the observed time at risk and reported as incidence rate per 100 person-years. Rate of breakthrough SARS-CoV-2 infection among fully vaccinated participants was reported in this outcome measure.
Measured: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Time to SARS-CoV-2 Breakthrough Infection
Time to SARS-CoV-2 breakthrough infection was calculated as the number of days from Dose 2 of vaccination till first occurrence of a breakthrough SARS-CoV-2 infection.
Measured: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Secondary outcomes (9)
Number of Participants With Emergency Department Visits After SARS-CoV-2 Infection
In this outcome measure, number of participants with emergency department visits who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed. Emergency department visits included an outpatient claim that occurs after the breakthrough COVID-19 diagnosis date or at the same time or episode of care.
Measured: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Number of Participants With Outpatient Hospital Visits After SARS-CoV-2 Infection
In this outcome measure, number of participants with outpatient hospital visits who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed. Outpatient hospital visits included an outpatient claim that occurs after the breakthrough COVID-19 diagnosis date or at the same time or episode of care other than emergency department visits.
Measured: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Number of Participants With Other Outpatient Visits After SARS-CoV-2 Infection
In this outcome measure, number of participants with other outpatient visits (excluding emergency department visits and outpatient hospital visits) who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.
Measured: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Number of Participants Hospitalized After SARS-CoV-2 Infection
In this outcome measure, number of participants hospitalized who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.
Measured: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization After SARS-CoV-2 Infection
In this outcome measure, number of participants admitted to ICU with or without Invasive Mechanical Ventilation (IMV) during hospitalization who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.
Measured: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Number of Participants Who Received Invasive Mechanical Ventilation (IMV) During Hospitalization After SARS-CoV-2 Infection
In this outcome measure, number of participants who received IMV with or without ICU admission during hospitalization who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.
Measured: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Number of Participants Died During Hospitalization After SARS-CoV-2 Infection
In this outcome measure, number of participants who died during hospitalization who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.
Measured: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Total Duration of Stay in Hospital After SARS-CoV-2 Infection
Total duration of stay was total time spend by the participant for different types of hospitalization treatments, applicable for first hospitalization and/or readmissions.
Measured: From Dose 2 of COVID-19 vaccination till the end of study (retrospective data was retrieved and observed during 4 months of this study)
Total Expenditure on Healthcare Resource Utilization (HCRU) After SARS-CoV-2 Infection
Total expenditure on HCRU was defined as total non-zero costs associated with any of the previously listed outpatient and inpatient encounters.
Measured: From Dose 2 of COVID-19 vaccination till the end of study (retrospective data was retrieved and observed during 4 months of this study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start25 Aug 2021
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
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.
- Other trials for ImmunocompromisedStudies 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
- 1,277,747 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
- NCT05020145
- Sponsor's protocol ID
- C4591035
- Status last verified
- Feb 2024
- First submitted
- 18 Aug 2021
- Last updated
- 12 Feb 2024
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronavirus Disease 2019 (COVID-19) Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States
- ClinicalTrials.gov ID
- NCT05020145
- Acronym / sponsor ID
- C4591035
- Conditions
- Immunocompromised, Immunosuppressed, Covid-19, SARS-COV-2, SARS-COV-2 Infection, Breakthrough Infection
- Keywords
- Immunocompromised, Immunosuppressed, Immunosuppressive drugs, Covid-19, Covid-19 Vaccination, mRNA Vaccine, SARS-CoV-2 Vaccine, BNT162b2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,277,747 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Posted 12 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective study will evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination.
Detailed description
The objective of this US-based retrospective cohort study is to evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination.
Subjects will be aged 12 years and older and will have no evidence of prior SARS-CoV-2 infection.
The primary analysis will be conducted on subjects vaccinated with BNT162b2.
A variety of subgroup analyses and sensitivity analyses are planned.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immunocompromised | – | Biological: BNT162b2 (Tozinameran)Vaccinated Subject with 1 or >1 immunocompromising conditions. |
| Non-Immunocompromised | – | Biological: BNT162b2 (Tozinameran)Vaccinated subjects without evidence of immunocompromising condition. |
| Total Population (immunocompromised and non) | – | Biological: BNT162b2 (Tozinameran)Vaccinated Subjects with or without 1 or >1 immunocompromising conditions. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The main study population consists of subjects >12 that received Covid-19 vaccination, had no evidence of prior infection, had continuous enrollment and evidence of immunocompromising conditions during the baseline pre vaccination period.
Key inclusion criteria (7 listed)
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Unique enrollees in the HealthVerity Vaccine dataset anytime after December 10, 2020
- At least 12 years on the index date (ie, first vaccination date)
- No evidence of prior COVID-19 infection (a medical claim, pharmacy claim, or chargemaster record with a diagnosis code of ICD-10-CM U07.1) in the 12 months prior to the index date
- Have 12 months of continuous enrollment with medical benefits (with or without pharmacy benefits) prior to the index date.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BNT162b2 (Tozinameran)Also: Pfizer-BioNTech COVID-19 vaccineCovid-19 Vaccine | Biological | Immunocompromised, Non-Immunocompromised, Total Population (immunocompromised and non) |
Primary outcome
Incidence Rate of Breakthrough Cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
Time frame: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
The incidence rate of breakthrough cases of SARS-CoV-2 infection was calculated as the number of participants who experienced the event divided by the observed time at risk and reported as incidence rate per 100 person-years. Rate of breakthrough SARS-CoV-2 infection among fully vaccinated participants was reported in this outcome measure.
Time to SARS-CoV-2 Breakthrough Infection
Time frame: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Time to SARS-CoV-2 breakthrough infection was calculated as the number of days from Dose 2 of vaccination till first occurrence of a breakthrough SARS-CoV-2 infection.
9 secondary outcomes
Number of Participants With Emergency Department Visits After SARS-CoV-2 Infection
Time frame: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Number of Participants With Outpatient Hospital Visits After SARS-CoV-2 Infection
Time frame: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Number of Participants With Other Outpatient Visits After SARS-CoV-2 Infection
Time frame: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Number of Participants Hospitalized After SARS-CoV-2 Infection
Time frame: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization After SARS-CoV-2 Infection
Time frame: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Number of Participants Who Received Invasive Mechanical Ventilation (IMV) During Hospitalization After SARS-CoV-2 Infection
Time frame: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Number of Participants Died During Hospitalization After SARS-CoV-2 Infection
Time frame: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
Total Duration of Stay in Hospital After SARS-CoV-2 Infection
Time frame: From Dose 2 of COVID-19 vaccination till the end of study (retrospective data was retrieved and observed during 4 months of this study)
Total Expenditure on Healthcare Resource Utilization (HCRU) After SARS-CoV-2 Infection
Time frame: From Dose 2 of COVID-19 vaccination till the end of study (retrospective data was retrieved and observed during 4 months of this study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Immunocompromised and Immunosuppressed, 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 7 inclusion and 0 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 12 Feb 2024. 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 12 Feb 2024). 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?
Incidence Rate of Breakthrough Cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (time frame: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.