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

Completed
Conditions
Breakthrough Infection
Covid-19
Immunosuppressed
SARS-COV-2 Infection
Immunocompromised
SARS-COV-2
Interventions
Biological: BNT162b2 (Tozinameran)
Registration Number
NCT05020145
Lead Sponsor
Pfizer
Brief Summary

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1277747
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.

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
ImmunocompromisedBNT162b2 (Tozinameran)Vaccinated Subject with 1 or \>1 immunocompromising conditions.
Non-ImmunocompromisedBNT162b2 (Tozinameran)Vaccinated subjects without evidence of immunocompromising condition.
Total Population (immunocompromised and non)BNT162b2 (Tozinameran)Vaccinated Subjects with or without 1 or \>1 immunocompromising conditions.
Primary Outcome Measures
NameTimeMethod
Incidence Rate of Breakthrough Cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) InfectionFrom 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 InfectionFrom 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.

Secondary Outcome Measures
NameTimeMethod
Number of Participants With Other Outpatient Visits After SARS-CoV-2 InfectionFrom 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.

Number of Participants With Emergency Department Visits After SARS-CoV-2 InfectionFrom 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.

Number of Participants Hospitalized After SARS-CoV-2 InfectionFrom 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.

Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization After SARS-CoV-2 InfectionFrom 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.

Number of Participants With Outpatient Hospital Visits After SARS-CoV-2 InfectionFrom 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.

Number of Participants Who Received Invasive Mechanical Ventilation (IMV) During Hospitalization After SARS-CoV-2 InfectionFrom 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.

Number of Participants Died During Hospitalization After SARS-CoV-2 InfectionFrom 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.

Total Duration of Stay in Hospital After SARS-CoV-2 InfectionFrom 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.

Total Expenditure on Healthcare Resource Utilization (HCRU) After SARS-CoV-2 InfectionFrom 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.

Trial Locations

Locations (1)

Pfizer Inc.

πŸ‡ΊπŸ‡Έ

New York, New York, United States

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