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

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05876377
Collaborator
(none)
18,000,000
Enrollment
2.9
Anticipated Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase
  • Biological: Pfizer-BioNTech COVID-19 bivalent mRNA vaccine

Study Design

Study Type:
Observational
Anticipated Enrollment :
18000000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Title Not in Corporate Clinical Trial Registry (CCTR)
Anticipated Study Start Date :
Jun 5, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with Post-COVID condition (PCC) defined as a composite of 3 definitions [29-120 days after COVID-19 diagnosis]

      A diagnosis of PCC using the ICD-10-CM code OR new onset of specific conditions (Cardiovascular, Hemolytic and Vascular, Pulmonary, Renal, gastrointestinal, Neurologic, Endocrine or Mental health) OR new onset of any commonly experienced diagnosis or symptom.

    2. Number of patients with an mRNA bivalent vaccination [Date of vaccine authorization through a minimum of 8 months]

      Any record of mRNA bivalent vaccination as recorded in the state immunization registry.

    Secondary Outcome Measures

    1. Number of patients with PCC defined using the ICD-10-CM code [29-120 days after COVID-19 diagnosis]

    2. Number of patients with PCC defined with a new specific condition [29-120 days after COVID-19 diagnosis]

      A new onset of any of the following specific conditions (Cardiovascular, Hemolytic and Vascular, Pulmonary, Renal, gastrointestinal, Neurologic, Endocrine or Mental health)

    3. Number of patients with a new PCC defined with commonly experienced diagnoses or symptoms [29-120 days after COVID-19 diagnosis]

    4. Number of patients with PCC defined with a new diagnosis for a cardiovascular condition [29-120 days after COVID-19 diagnosis]

    5. Number of patients with PCC defined with a new diagnosis for a hemolytic/vascular condition [29-120 days after COVID-19 diagnosis]

    6. Number of patients with PCC defined with a diagnosis for a new pulmonary condition [29-120 days after COVID-19 diagnosis]

    7. Number of patients with PCC defined with a diagnosis for a new musculoskeletal condition [29-120 days after COVID-19 diagnosis]

    8. Number of patients with PCC defined with a new diagnosis for a renal condition [29-120 days after COVID-19 diagnosis]

    9. Number of patients with PCC defined with a diagnosis for a new gastrointestinal condition [29-120 days after COVID-19 diagnosis]

    10. Number of patients with PCC defined with a diagnosis for a new neurologic condition [29-120 days after COVID-19 diagnosis]

    11. Number of patients with PCC defined with a diagnosis for a new endocrine condition [29-120 days after COVID-19 diagnosis]

    12. Number of patients with PCC defined with a diagnosis for a new mental health condition [29-120 days after COVID-19 diagnosis]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 99 Years
    Sexes Eligible for Study:
    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

    3. Exclude patients ≥12 years old who received a bivalent mRNA COVID-19 vaccine booster prior to 31 August 2022

    4. Exclude patients 5-11 years old (inclusive) who received a bivalent mRNA COVID-19 vaccine booster prior to 12 October 2022

    5. Exclude patients 6 months to 4 years old (inclusive) who received a bivalent mRNA COVID-19 vaccine booster prior to 08 December 2022.

    6. Receipt of the bivalent mRNA COVID-19 vaccine booster prior to being eligible

    1. Exclude patients who received the bivalent mRNA COVID-19 vaccine booster <2 months since receipt of the most recent prior monovalent dose.

    1. Exclude patients who have had >1 bivalent mRNA COVID-19 vaccine dose

    2. Exclude patients who have had ≥5 monovalent mRNA COVID-19 vaccine doses

    3. Exclude patients who have had any non-mRNA COVID-19 vaccine

    4. Exclude patients who had a Moderna COVID-19 Vaccine, Bivalent booster

    5. Exclude patients who are immunocompromised or pregnant.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT05876377
    Other Study ID Numbers:
    • C4591059
    First Posted:
    May 25, 2023
    Last Update Posted:
    May 25, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Pfizer
    COVID-19 Vaccines
    COVID-19 Drug Treatment
    Additional relevant MeSH terms:
    COVID-19
    Post-Acute COVID-19 Syndrome
    Vaccines

    Study Results

    No Results Posted as of May 25, 2023