N/A
N=1,277,747
COVID-19 Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States
Immunocompromised · Immunosuppressed · Covid-19 · SARS-COV-2 · SARS-COV-2 Infection
Bottom Line
View on ClinicalTrials.gov: NCT05020145 ↗Enrolled (actual)
1,277,747
Serious AEs
—
Results posted
Feb 2024
Primary outcome: Primary: Incidence Rate of Breakthrough Cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection — 0.89; 0.34 Events per 100 person-years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- BNT162b2 (Tozinameran) (Biological)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Breakthrough Cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection |
0.89; 0.34 | — |
| PRIMARY Time to SARS-CoV-2 Breakthrough Infection |
34.5; 33 | — |
| SECONDARY Number of Participants With Emergency Department Visits After SARS-CoV-2 Infection |
95; 72 | — |
| SECONDARY Number of Participants With Outpatient Hospital Visits After SARS-CoV-2 Infection |
146; 164 | — |
| SECONDARY Number of Participants With Other Outpatient Visits After SARS-CoV-2 Infection |
309; 527 | — |
| SECONDARY Number of Participants Hospitalized After SARS-CoV-2 Infection |
74; 50 | — |
| SECONDARY Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization After SARS-CoV-2 Infection |
15; 9; 8; 1 | — |
| SECONDARY Number of Participants Who Received Invasive Mechanical Ventilation (IMV) During Hospitalization After SARS-CoV-2 Infection |
8; 1; 1; 0 | — |
| SECONDARY Number of Participants Died During Hospitalization After SARS-CoV-2 Infection |
2; 0 | — |
| SECONDARY Total Duration of Stay in Hospital After SARS-CoV-2 Infection |
— | — |
| SECONDARY Total Expenditure on Healthcare Resource Utilization (HCRU) After SARS-CoV-2 Infection |
— | — |
Summary
This retrospective study will evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination.
Eligibility Criteria
Inclusion Criteria
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Unique enrollees in the HealthVerity Vaccine dataset anytime after December 10, 2020
- At least 12 years on the index date (ie, first vaccination date)
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT05020145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.