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

Completed
Immunocompromised
Immunosuppressed
COVID-19
SARS-CoV-2
SARS-CoV-2 Infection
Breakthrough Infection

Biological: BNT162b2 (Tozinameran)

Covid-19 Vaccine
Other Name: Pfizer-BioNTech COVID-19 vaccine

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
United States
Locations

Pfizer Inc.
New York, New York, United States

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
Keywords
Immunocompromised
Immunosuppressed
Immunosuppressive drugs
Covid-19
COVID-19 vaccination
mRNA Vaccine
SARS-CoV-2 Vaccine
BNT162b2
breakthrough infection
SARS-CoV-2 infection
SARS-CoV-2
MeSH Terms
Infections
Communicable Diseases
COVID-19
Breakthrough Infections
Vaccines