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

Pfizer

Status: Completed

Conditions: Immunosuppressed; SARS-COV-2; SARS-COV-2 Infection; Breakthrough Infection; Covid-19; Immunocompromised

Treatments: Biological: BNT162b2 (Tozinameran)

Study type: Observational

Funder types: Industry

Identifiers

NCT05020145

C4591035

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,277,747 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

1,277,747 participants in 3 patient groups

Immunocompromised

Description:

Vaccinated Subject with 1 or \>1 immunocompromising conditions.

Treatment:

Biological: BNT162b2 (Tozinameran)

Non-Immunocompromised

Description:

Vaccinated subjects without evidence of immunocompromising condition.

Treatment:

Biological: BNT162b2 (Tozinameran)

Total Population (immunocompromised and non)

Description:

Vaccinated Subjects with or without 1 or \>1 immunocompromising conditions.

Treatment:

Biological: BNT162b2 (Tozinameran)