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

Sponsor
Pfizer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05020145
Collaborator
(none)
70,000
Enrollment
1
Location
4.2
Anticipated Duration (Months)
16645.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: BNT162b2 (Tozinameran)

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
70000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
COVID-19 Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States
Actual Study Start Date :
Aug 25, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

ArmIntervention/Treatment
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
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence Rate of Breakthrough SARS-CoV-2 Infection [From completion of vaccination through the end of the study period, up to approximately one year]

      Among subjects who meet the definition of fully vaccinated, a breakthrough SARS-CoV-2 infection will be defined by evidence of a claim with a diagnosis code of U07.1 that occurs >14 days after the second vaccination date. Incidence rates will be calculated as the number of breakthrough infections divided by the time at risk.

    2. Time to Breakthrough SARS-CoV-2 Infection [From completion of vaccination through the end of the study period, up to approximately one year]

      Days from the completion of vaccination to the first occurrence of a Breakthrough SARS-CoV-2 Infection.

    Secondary Outcome Measures

    1. Outpatient Hospital Visit [From completion of vaccination through the end of the study period, up to approximately one year]

      Number of outpatient hospital visits due to SARS-CoV-2.

    2. Emergency Hospital Visit [From completion of vaccination through the end of the study period, up to approximately one year]

      Number of emergency hospital visits due to SARS-CoV-2.

    3. Other Outpatient Visit (Non- Emergency, Not Hospital based) [From completion of vaccination through the end of the study period, up to approximately one year]

      Number of other outpatient encounters due to SARS-CoV-2 (excluding emergency hospital visits and outpatient hospital visits).

    4. Hospitalization [From completion of vaccination through the end of the study period, up to approximately one year]

      Number of subjects hospitalized due to SARS-CoV-2.

    5. Intensive Care Unit [From completion of vaccination through the end of the study period, up to approximately one year]

      Number of admissions to the Intensive Care Unit due to SARS-CoV-2.

    6. Invasive Mechanical Ventilation/ECMO [From completion of vaccination through the end of the study period, up to approximately one year]

      Number of subjects requiring Invasive Mechanical Ventilation/ECMO (Extracorporeal membrane oxygenation) due to SARS-CoV-2.

    7. Inpatient Death [From completion of vaccination through the end of the study period, up to approximately one year]

      Number of deaths that occur during a hospitalization due to SARS-CoV-2 infection.

    8. Length of Stay (LOS) [From completion of vaccination through the end of the study period, up to approximately one year]

      Days from admission in hospital to discharge.

    9. Total Costs [From completion of vaccination through the end of the study period, up to approximately one year]

      Non-zero costs associated with any of the previously listed Outpatient and Inpatient encounters (but death). Costs will be measured in USD.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Pfizer Inc.New YorkNew YorkUnited States10021

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT05020145
    Other Study ID Numbers:
    • C4591035
    First Posted:
    Aug 25, 2021
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Pfizer
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 16, 2021