Purpose

This study aims to use vaccination information from the California Immunization Registry linked with HealthVerity insurance claims for patients residing in California for the following: - to measure effectiveness of the Pfizer-BioNTech bivalent booster against post-COVID conditions. - to understand characteristics of patients who are receiving COVID-19 vaccines. All patients who have been de-identified in the HealthVerity database are eligible to be included for both aims of this study.

Conditions

Eligibility

Eligible Ages
Over 6 Months
Eligible Genders
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. Include patients whose claims records and vaccine registry data are both available in the HealthVerity databases 2. Include patients who are eligible to receive the bivalent booster during the study period - ≥2 monovalent doses have been received - ≥2 months have elapsed since the most recent prior monovalent dose.

Exclusion Criteria

Patients meeting any of the following criteria will not be included in the study: 1. Exclude patients with a PCC episode prior to being eligible for the bivalent mRNA COVID-19 vaccine booster 2. Receipt of the bivalent mRNA COVID-19 vaccine booster prior to authorization 1. Exclude patients ≥12 years old who received a bivalent mRNA COVID-19 vaccine booster prior to 31 August 2022 2. Exclude patients 5-11 years old (inclusive) who received a bivalent mRNA COVID-19 vaccine booster prior to 12 October 2022 3. Exclude patients 6 months to 4 years old (inclusive) who received a bivalent mRNA COVID-19 vaccine booster prior to 08 December 2022. 3. Receipt of the bivalent mRNA COVID-19 vaccine booster prior to being eligible a. Exclude patients who received the bivalent mRNA COVID-19 vaccine booster <2 months since receipt of the most recent prior monovalent dose. 4. Exclude patients who have had >1 bivalent mRNA COVID-19 vaccine dose 5. Exclude patients who have had ≥5 monovalent mRNA COVID-19 vaccine doses 6. Exclude patients who have had any non-mRNA COVID-19 vaccine 7. Exclude patients who had a Moderna COVID-19 Vaccine, Bivalent booster 8. Exclude patients who are immunocompromised or pregnant.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Boosted with Pfizer-BioNTech COVID-19 bivalent mRNA vaccine Patient identified in the vaccine registry having a single dose Pfizer-BioNTech COVID-19 bivalent mRNA vaccine after completion of the primary series
  • Biological: Pfizer-BioNTech COVID-19 bivalent mRNA vaccine
    Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.
    Other names:
    • Pfizer-BioNTech COVID-19 Vaccine, Bivalent
Not Boosted with Pfizer-BioNTech COVID-19 bivalent mRNA vaccine Patient not located in the vaccine registry having a single dose Pfizer-BioNTech COVID-19 bivalent mRNA vaccine after completion of the primary series

Recruiting Locations

Pfizer
New York, New York 10001

More Details

NCT ID
NCT05876377
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.