NCT05020145 is a clinical trial of BNT162b2 (Tozinameran) in Immunocompromised, sponsored by Pfizer.

Who is sponsoring NCT05020145?

NCT05020145 is sponsored by Pfizer.

What drugs are being tested in NCT05020145?

Interventions in NCT05020145: BNT162b2 (Tozinameran).

What condition does NCT05020145 study?

NCT05020145 studies Immunocompromised, Immunosuppressed, Covid-19, SARS-COV-2, SARS-COV-2 Infection, Breakthrough Infection.

Is NCT05020145 still recruiting?

NCT05020145 is currently completed. Last updated 12 February 2024.

Are results published for NCT05020145?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-02-12 · How we verify

NCT05020145

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

COVID-19 Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States

Completed Results posted Last updated 12 February 2024

What this trial tests

trial testing BNT162b2 (Tozinameran) in Immunocompromised in 1,277,747 participants. Completed in 17 December 2021.

Timeline

25 August 2021

Primary endpoint
17 December 2021

17 December 2021

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,277,747
Start date	25 August 2021
Primary completion	17 December 2021
Estimated completion	17 December 2021
Sites	1 location across United States

Drugs / interventions tested

BNT162b2 (Tozinameran) — full drug profile →

Conditions studied

Immunocompromised — all drugs for Immunocompromised →
Immunosuppressed — all drugs for Immunosuppressed →
Covid-19 — all drugs for Covid-19 →
SARS-COV-2 — all drugs for SARS-COV-2 →

Sponsor

Pfizer — full company profile →

Who can join

12 and older, any sex, with Immunocompromised or Immunosuppressed. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence Rate of Breakthrough Cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Primary · 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.

Group	Value	95% CI
BNT162b2 (Tozinameran): IC Cohort	0.89	0.80 – 0.98
BNT162b2 (Tozinameran): Non-IC Cohort	0.34	0.32 – 0.37

Time to SARS-CoV-2 Breakthrough Infection Primary · 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.

Group	Value	95% CI
BNT162b2 (Tozinameran): IC Cohort	34.5	22 – 58
BNT162b2 (Tozinameran): Non-IC Cohort	33	20.5 – 58

Number of Participants With Emergency Department Visits After SARS-CoV-2 Infection Secondary · 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)

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.

Group	Value	95% CI
BNT162b2 (Tozinameran): IC Cohort	95
BNT162b2 (Tozinameran): Non-IC Cohort	72

Number of Participants With Outpatient Hospital Visits After SARS-CoV-2 Infection Secondary · 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)

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.

Group	Value	95% CI
BNT162b2 (Tozinameran): IC Cohort	146
BNT162b2 (Tozinameran): Non-IC Cohort	164

Number of Participants With Other Outpatient Visits After SARS-CoV-2 Infection Secondary · 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)

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.

Group	Value	95% CI
BNT162b2 (Tozinameran): IC Cohort	309
BNT162b2 (Tozinameran): Non-IC Cohort	527

Number of Participants Hospitalized After SARS-CoV-2 Infection Secondary · 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)

In this outcome measure, number of participants hospitalized who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.

Group	Value	95% CI
BNT162b2 (Tozinameran): IC Cohort	74
BNT162b2 (Tozinameran): Non-IC Cohort	50

Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization After SARS-CoV-2 Infection Secondary · 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)

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.

With ICU admission and no IMV usage

Group	Value	95% CI
BNT162b2 (Tozinameran): IC Cohort	15
BNT162b2 (Tozinameran): Non-IC Cohort	9

With ICU admission and IMV usage

Group	Value	95% CI
BNT162b2 (Tozinameran): IC Cohort	8
BNT162b2 (Tozinameran): Non-IC Cohort	1

Number of Participants Who Received Invasive Mechanical Ventilation (IMV) During Hospitalization After SARS-CoV-2 Infection Secondary · 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)

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.

With ICU admission and IMV usage

Group	Value	95% CI
BNT162b2 (Tozinameran): IC Cohort	8
BNT162b2 (Tozinameran): Non-IC Cohort	1

No ICU admission with IMV usage

Group	Value	95% CI
BNT162b2 (Tozinameran): IC Cohort	1
BNT162b2 (Tozinameran): Non-IC Cohort	0

Number of Participants Died During Hospitalization After SARS-CoV-2 Infection Secondary · 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)

In this outcome measure, number of participants who died during hospitalization who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.

Group	Value	95% CI
BNT162b2 (Tozinameran): IC Cohort	2
BNT162b2 (Tozinameran): Non-IC Cohort	0

Sponsor's own description

This retrospective study will evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Progress and prospects of mRNA-based drugs in pre-clinical and clinical applications.
Shi Y, Shi M, Wang Y, You J. · · 2024 · cited 67× · PMID 39543114 · DOI 10.1038/s41392-024-02002-z
Evaluation of COVID-19 vaccine breakthrough infections among immunocompromised patients fully vaccinated with BNT162b2
Di Fusco M, Moran MM, Cane A, Curcio D, et al · · 2021 · DOI 10.1101/2021.10.12.21264707

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05020145 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 12 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05020145.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing