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NCT05876377 | Recruiting | SARS-CoV-2

Effectiveness and Use of COVID-19 Vaccines Using Information From the California State Vaccine Registry
Sponsor:

Pfizer

Brief Summary:

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.

Condition or disease

SARS-CoV-2

COVID-19

Post-Acute COVID-19 Syndrome

Intervention/treatment

Pfizer-BioNTech COVID-19 bivalent mRNA vaccine

Study Type : Observational
Estimated Enrollment : 999 participants
Official Title : Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data
Actual Study Start Date : October 23, 2023
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : August 30, 2024

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Months
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study
    • Include patients whose claims records and vaccine registry data are both available in the HealthVerity databases
    • 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
      • Exclude patients with a PCC episode prior to being eligible for the bivalent mRNA COVID-19 vaccine booster
      • Receipt of the bivalent mRNA COVID-19 vaccine booster prior to authorization
      • Exclude patients ≥12 years old who received a bivalent mRNA COVID-19 vaccine booster prior to 31 August 2022
      • Exclude patients 5-11 years old (inclusive) who received a bivalent mRNA COVID-19 vaccine booster prior to 12 October 2022
      • Exclude patients 6 months to 4 years old (inclusive) who received a bivalent mRNA COVID-19 vaccine booster prior to 08 December 2022.
      • 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.
      • Exclude patients who have had >1 bivalent mRNA COVID-19 vaccine dose
      • Exclude patients who have had ≥5 monovalent mRNA COVID-19 vaccine doses
      • Exclude patients who have had any non-mRNA COVID-19 vaccine
      • Exclude patients who had a Moderna COVID-19 Vaccine, Bivalent booster
      • Exclude patients who are immunocompromised or pregnant.
Effectiveness and Use of COVID-19 Vaccines Using Information From the California State Vaccine Registry

Location Details

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Effectiveness and Use of COVID-19 Vaccines Using Information From the California State Vaccine Registry

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, New York

Pfizer

New York, New York, United States, 10001