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

COVID-19 Clinical Trial

Official title:

Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05876377
• Other study ID #: C4591059
• Status: Recruiting
• Start date: October 23, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 999
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

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.

Locations

Country	Name	City	State
United States	Pfizer	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Post-COVID condition (PCC) defined as a composite of 3 definitions	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.	29-120 days after COVID-19 diagnosis
Primary	Number of patients with an mRNA bivalent vaccination	Any record of mRNA bivalent vaccination as recorded in the state immunization registry.	Date of vaccine authorization through a minimum of 8 months
Secondary	Number of patients with PCC defined using the ICD-10-CM code		29-120 days after COVID-19 diagnosis
Secondary	Number of patients with PCC defined with a new specific condition	A new onset of any of the following specific conditions (Cardiovascular, Hemolytic and Vascular, Pulmonary, Renal, gastrointestinal, Neurologic, Endocrine or Mental health)	29-120 days after COVID-19 diagnosis
Secondary	Number of patients with a new PCC defined with commonly experienced diagnoses or symptoms		29-120 days after COVID-19 diagnosis
Secondary	Number of patients with PCC defined with a new diagnosis for a cardiovascular condition		29-120 days after COVID-19 diagnosis
Secondary	Number of patients with PCC defined with a new diagnosis for a hemolytic/vascular condition		29-120 days after COVID-19 diagnosis
Secondary	Number of patients with PCC defined with a diagnosis for a new pulmonary condition		29-120 days after COVID-19 diagnosis
Secondary	Number of patients with PCC defined with a diagnosis for a new musculoskeletal condition		29-120 days after COVID-19 diagnosis
Secondary	Number of patients with PCC defined with a new diagnosis for a renal condition		29-120 days after COVID-19 diagnosis
Secondary	Number of patients with PCC defined with a diagnosis for a new gastrointestinal condition		29-120 days after COVID-19 diagnosis
Secondary	Number of patients with PCC defined with a diagnosis for a new neurologic condition		29-120 days after COVID-19 diagnosis
Secondary	Number of patients with PCC defined with a diagnosis for a new endocrine condition		29-120 days after COVID-19 diagnosis
Secondary	Number of patients with PCC defined with a diagnosis for a new mental health condition		29-120 days after COVID-19 diagnosis

External Links

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