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

Purpose

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

Conditions

  • Immunocompromised
  • Immunosuppressed
  • Covid-19
  • SARS-COV-2
  • SARS-COV-2 Infection
  • Breakthrough Infection

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT05020145
Status
Completed
Sponsor
Pfizer

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.