Clinical trial NCT05020145: COVID-19 Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States
Official title: Coronavirus Disease 2019 (COVID-19) Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunocompromised
Immunosuppressed
Covid-19
SARS-COV-2
SARS-COV-2 Infection
Breakthrough Infection
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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-08-25
Enrollment: 1277747
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The main study population consists of subjects \>12 that received Covid-19 vaccination, had no evidence of prior infection, had continuous enrollment and evidence of immunocompromising conditions during the baseline pre vaccination period.

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.

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.

Primary outcomes:
measure: Incidence Rate of Breakthrough Cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
timeFrame: 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)
measure: Time to SARS-CoV-2 Breakthrough Infection
timeFrame: 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)
Secondary outcomes:
measure: Number of Participants With Emergency Department Visits After SARS-CoV-2 Infection
timeFrame: 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)
measure: Number of Participants With Outpatient Hospital Visits After SARS-CoV-2 Infection
timeFrame: 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)
measure: Number of Participants With Other Outpatient Visits After SARS-CoV-2 Infection
timeFrame: 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)
measure: Number of Participants Hospitalized After SARS-CoV-2 Infection
timeFrame: 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)
measure: Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization After SARS-CoV-2 Infection
timeFrame: 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)
measure: Number of Participants Who Received Invasive Mechanical Ventilation (IMV) During Hospitalization After SARS-CoV-2 Infection
timeFrame: 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)
measure: Number of Participants Died During Hospitalization After SARS-CoV-2 Infection
timeFrame: 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)
measure: Total Duration of Stay in Hospital After SARS-CoV-2 Infection
timeFrame: From Dose 2 of COVID-19 vaccination till the end of study (retrospective data was retrieved and observed during 4 months of this study)
measure: Total Expenditure on Healthcare Resource Utilization (HCRU) After SARS-CoV-2 Infection
timeFrame: From Dose 2 of COVID-19 vaccination till the end of study (retrospective data was retrieved and observed during 4 months of this study)
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer Inc.
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: