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

NCT05020145 | Completed Results FDA Drug

• 1 other identifier: C4591035
• Study Type: observational
• Target: 1,277,747
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (2)

• Incidence Rate of Breakthrough Cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

  The incidence rate of breakthrough cases of SARS-CoV-2 infection was calculated as the number of participants who experienced the event divided by the observed time at risk and reported as incidence rate per 100 person-years. Rate of breakthrough SARS-CoV-2 infection among fully vaccinated participants was reported in this outcome measure.

  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)

• Time to SARS-CoV-2 Breakthrough Infection

  Time to SARS-CoV-2 breakthrough infection was calculated as the number of days from Dose 2 of vaccination till first occurrence of a breakthrough SARS-CoV-2 infection.

  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 (9)

• Number of Participants With Emergency Department Visits After SARS-CoV-2 Infection

  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)

• Number of Participants With Outpatient Hospital Visits After SARS-CoV-2 Infection

  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)

• Number of Participants With Other Outpatient Visits After SARS-CoV-2 Infection

  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)

• Number of Participants Hospitalized After SARS-CoV-2 Infection

  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)

• Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization After SARS-CoV-2 Infection

  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)

Study Arms (3)

Immunocompromised

Vaccinated Subject with 1 or \>1 immunocompromising conditions.

Biological: BNT162b2 (Tozinameran)

Non-Immunocompromised

Vaccinated subjects without evidence of immunocompromising condition.

Biological: BNT162b2 (Tozinameran)

Total Population (immunocompromised and non)

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

Biological: BNT162b2 (Tozinameran)

Interventions

BNT162b2 (Tozinameran) BIOLOGICAL

Covid-19 Vaccine

Also known as: Pfizer-BioNTech COVID-19 vaccine

Immunocompromised; Non-Immunocompromised; Total Population (immunocompromised and non)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Inc.

New York, New York, 10021, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

COVID-19; Breakthrough Infections

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Limitations and Caveats

Data for outcome measures- Total duration of stay in hospital after SARS-COV-2 infection and total expenditure on healthcare resource utilization (HCRU) after SARS-COV-2 infection was not collected and analyzed as per Sponsor discretion.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 25, 2021
• Study Start: August 25, 2021
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: February 12, 2024
• Results First Posted: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)