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

February 8, 2024 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1277747

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Pfizer Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. Unique enrollees in the HealthVerity Vaccine dataset anytime after December 10, 2020
  2. At least 12 years on the index date (ie, first vaccination date)
  3. 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
  4. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Immunocompromised
Vaccinated Subject with 1 or >1 immunocompromising conditions.
Biological: BNT162b2 (Tozinameran)
Covid-19 Vaccine
Other Names:
  • Pfizer-BioNTech COVID-19 vaccine
Non-Immunocompromised
Vaccinated subjects without evidence of immunocompromising condition.
Biological: BNT162b2 (Tozinameran)
Covid-19 Vaccine
Other Names:
  • Pfizer-BioNTech COVID-19 vaccine
Total Population (immunocompromised and non)
Vaccinated Subjects with or without 1 or >1 immunocompromising conditions.
Biological: BNT162b2 (Tozinameran)
Covid-19 Vaccine
Other Names:
  • Pfizer-BioNTech COVID-19 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
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)
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.
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)
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.
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)
In this outcome measure, number of participants hospitalized who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.
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)
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.
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)
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.
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)
In this outcome measure, number of participants who died during hospitalization who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.
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 duration of stay was total time spend by the participant for different types of hospitalization treatments, applicable for first hospitalization and/or readmissions.
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)
Total expenditure on HCRU was defined as total non-zero costs associated with any of the previously listed outpatient and inpatient encounters.
From Dose 2 of COVID-19 vaccination till the end of study (retrospective data was retrieved and observed during 4 months of this study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2021

Primary Completion (Actual)

December 17, 2021

Study Completion (Actual)

December 17, 2021

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4591035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid-19

Clinical Trials on BNT162b2 (Tozinameran)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe