NCT05020145

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,277,747 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Immunocompromised
• Immunosuppressed
• Covid-19
• SARS-COV-2
• SARS-COV-2 Infection
• Breakthrough Infection

Interventions

Type	Name	Description
BIOLOGICAL	BNT162b2 (Tozinameran)	Covid-19 Vaccine

Timeline

• Start date: 2021-08-25
• Primary completion: 2021-12-17
• Completion: 2021-12-17
• First posted: 2021-08-25
• Last updated: 2024-02-12
• Results posted: 2024-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study