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NCT Number: NCT05020145

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.

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Key information

Conditions

Immunocompromised Breakthrough Infection Breakthrough Infections COVID-19 Coronaviridae Infections Coronavirus Infections Disease Attributes Immunosuppressed Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Sars-CoV-2 Infection Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Inc.

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Treatment and study plan

BNT162b2 (Tozinameran)

Biological

Covid-19 Vaccine

Other names: Pfizer-BioNTech COVID-19 vaccine

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Coronavirus Disease 2019 (COVID-19) Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 25, 2021
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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