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Title Not in Corporate Clinical Trial Registry (CCTR): Coronavirus – COVID-19

2023 JUN 13 (NewsRx) -- By a News Reporter-Staff News Editor at Vaccine Daily -- Staff editors report on the newly launched clinical trial, NCT05876377, which has the following summary description: “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.”

As a matter of record, on May 26, 2023, NewsRx staff editors report that the available information provided by Pfizer on this trial include:

Tracking Information

Trial Identifier NCT05876377
First Submitted Date May 23, 2023
First Posted Date May 25, 2023
Results First Submitted Date Not Provided
Results First Posted Date Not Provided
Last Update Submitted Date May 23, 2023
Last Update Posted Date May 25, 2023
Primary Completion Date August 31, 2023
Start Date June 5, 2023
Current Primary Outcome Measures •Number of patients with Post-COVID condition (PCC) defined as a composite of 3 definitions [ Time Frame: 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.
•Number of patients with an mRNA bivalent vaccination [ Time Frame: Date of vaccine authorization through a minimum of 8 months ] -- Any record of mRNA bivalent vaccination as recorded in the state immunization registry.
Current Secondary Outcome Measures •Number of patients with PCC defined using the ICD-10-CM code [ Time Frame: 29-120 days after COVID-19 diagnosis ]
•Number of patients with PCC defined with a new specific condition [ Time Frame: 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)
•Number of patients with a new PCC defined with commonly experienced diagnoses or symptoms [ Time Frame: 29-120 days after COVID-19 diagnosis ]
•Number of patients with PCC defined with a new diagnosis for a cardiovascular condition [ Time Frame: 29-120 days after COVID-19 diagnosis ]
•Number of patients with PCC defined with a new diagnosis for a hemolytic/vascular condition [ Time Frame: 29-120 days after COVID-19 diagnosis ]
•Number of patients with PCC defined with a diagnosis for a new pulmonary condition [ Time Frame: 29-120 days after COVID-19 diagnosis ]
•Number of patients with PCC defined with a diagnosis for a new musculoskeletal condition [ Time Frame: 29-120 days after COVID-19 diagnosis ]
•Number of patients with PCC defined with a new diagnosis for a renal condition [ Time Frame: 29-120 days after COVID-19 diagnosis ]
•Number of patients with PCC defined with a diagnosis for a new gastrointestinal condition [ Time Frame: 29-120 days after COVID-19 diagnosis ]
•Number of patients with PCC defined with a diagnosis for a new neurologic condition [ Time Frame: 29-120 days after COVID-19 diagnosis ]
•Number of patients with PCC defined with a diagnosis for a new endocrine condition [ Time Frame: 29-120 days after COVID-19 diagnosis ]
•Number of patients with PCC defined with a diagnosis for a new mental health condition [ Time Frame: 29-120 days after COVID-19 diagnosis ]
Other Outcome Measures Not Provided
Change History Complete list of historical revisions of study NCT05876377

Descriptive Information

Brief Title Effectiveness and Use of COVID-19 Vaccines Using Information From the California State Vaccine Registry
Official Title Title Not in Corporate Clinical Trial Registry (CCTR)
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.
Detailed Description Not Provided
Study Type Observational
Study Phase Not Provided
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Condition SARS-CoV-2
COVID-19
Post-Acute COVID-19 Syndrome
Intervention •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
Study Arms •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
Interventions:
⚬Biological: Pfizer-BioNTech COVID-19 bivalent mRNA vaccine

Recruitment Information

Recruitment Status Not yet recruiting
Estimated Enrollment 18000000
Estimated Completion Date August 31, 2023
Primary Completion Date August 31, 2023 (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender Sexes Eligible for Study: All
Ages 6 months to 99 years
Accepts Healthy Volunteers No
Contacts Primary contact: Pfizer CT.gov Call Center, 1-800-718-1021, [email protected]
Listed Location Countries Not Provided
Removed Location Countries

Administrative Information

NCT Number NCT05876377
Other Study ID Numbers C4591059
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Studies a U.S. FDA-Regulated Drug Product: Yes
Studies a U.S. FDA-Regulated Device Product: No
Plan to Share Data No
Plan to Share Data (IPD) Description Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer’s data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Collaborators Not Provided
Investigators Study Director: Pfizer CT.gov Call Center, Pfizer
Information Provided By Pfizer
Verification Date May 2023

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