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

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: May 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 state vaccine registries linked with HealthVerity insurance claims for the following:

• to measure how effective the Pfizer-BioNTech vaccine is at preventing post-COVID conditions.

• to understand characteristics of patients who are receiving COVID-19 vaccines.

All patients whose information is kept unidentified in the HealthVerity database are eligible to be included for both aims of this study.

Description:

We will assess the effectiveness of the COVID-19 vaccine in preventing post-vaccine health conditions. To do this, we will employ a target trial emulation design, examining the vaccine's effectiveness from the time it was authorized or approved, specifically for different age groups, up until the most recent available data. We will gather patient data from HealthVerity, including those enrolled in the claims database, and supplement it with information from the state's deidentified vaccine registry. Only patients eligible to receive the vaccine during the study period will be included in the analysis of post-vaccine health conditions. We will compare vaccinated individuals with those eligible for vaccination but not vaccinated, using various statistical methods such as descriptive statistics, incidence rates, hazard ratios, and survival curves.

The second part of our study will use a retrospective cohort design to examine the uptake of the vaccine in specific groups over time. We will identify subjects through two different methods: 1) by analyzing all available dosing records in the Immunization Registry, 2) by using HealthVerity claims data based on specific time periods when the vaccine was available. We will follow these individuals until they receive the vaccine under investigation, leave the study, reach the end of the available data, or pass away. We will assess overall vaccination rates and also analyze the data based on the specific type of prior vaccine dose received.

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 licensed/authorized vaccine during the study period

Exclusion Criteria:

Patients meeting any of the following criteria will not be included in the study:

1. Exclude patients with a condition of interest prior to being eligible for the mRNA COVID-19 vaccine booster

2. Receipt of the mRNA COVID-19 vaccine booster prior to date of licensure/authorization (i.e., September 11, 2023 for XBB formulation)

3. Receipt of the licensed/authorized mRNA COVID-19 vaccine prior to being eligible

a. Exclude patients who received the licensed/authorized vaccine <2 months since receipt of the most recent prior dose

4. Exclude patients who have had >1 mRNA COVID-19 vaccine dose of the current formulation prior to COVID-19 diagnosis

5. Exclude patients who had a non-Pfizer/BioNTech COVID-19 Vaccine of the current formulation prior to COVID-19 diagnosis

6. Exclude patients who are immunocompromised or pregnant at COVID-19 diagnosis

7. Exclude patients who die or disenroll within 28 days after COVID-19 diagnosis

8. Exclude patients who received a booster less than 14 days before COVID diagnosis

9. Exclude patients who receive a COVID-19 vaccine in the period between index (COVID diagnosis) and start of follow-up (31 days after COVID-19 diagnosis)

10. Exclude persons who had a COVID episode documented within 90 days prior to index, as the index infection is considered a recent reinfection.

11. Exclude persons who have discrepancies in sex and/or year of birth between HealthVerity claims and state Immunization registry datasets.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Biological:
• Pfizer-BioNTech COVID-19 mRNA vaccine
Pfizer-BioNTech COVID-19 Vaccine, is FDA licensed or 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
Other	Number of patients with Post-COVID condition (PCC) up to 180 days after infection	A sensitivity analysis will be conducted to extend follow-up to day 180 post diagnosis date for cardiopulmonary composite PCC diagnosis as defined by Xie et al. (doi:10.1001/jamainternmed.2023.0743). All patients are required to have a diagnosis of COVID-19 (ICD-10-CM code = U07.1) as an index event for the subsequent evaluation of a PCC episode. The first 30 days after the diagnosis of COVID-19 will be excluded from the evaluation of a PCC episode as the acute infection period. The evaluation of the PCC episode will begin on Day 31 after the date of COVID-19 diagnosis through day 180.	30-180 days after COVID-19 diagnosis
Primary	Number of patients with Post-COVID condition (PCC) up to 120 days after infection	The primary endpoint is a cardiopulmonary composite PCC diagnosis as defined by Xie et al. (doi:10.1001/jamainternmed.2023.0743). All patients are required to have a diagnosis of COVID-19 (ICD-10-CM code = U07.1) as an index event for the subsequent evaluation of a PCC episode. The first 30 days after the diagnosis of COVID-19 will be excluded from the evaluation of a PCC episode as the acute infection period. The evaluation of the PCC episode will begin on Day 31 after the date of COVID-19 diagnosis through day 120.	30-120 days after COVID-19 diagnosis
Primary	Number of patients with a COVID-19 vaccination	Any record of COVID-19 vaccination as recorded in the state immunization registry.	Date of vaccine authorization through the end of the corresponding respiratory season
Secondary	Number of patients with cardiovascular-specific Post-COVID condition (PCC) up to 120 days after infection	Secondary endpoints will evaluate PCC by specific organ classes as defined by Xie et al. (doi:10.1001/jamainternmed.2023.0743). All patients are required to have a diagnosis of COVID-19 (ICD-10-CM code = U07.1) as an index event for the subsequent evaluation of a cardiovascular-specific (i.e., dysrhythmia and/or ischemic heart disease) PCC episode. The first 30 days after the diagnosis of COVID-19 will be excluded from the evaluation of a PCC episode as the acute infection period. The evaluation of the cardiovascular-specific PCC episode will begin on Day 31 after the date of COVID-19 diagnosis through day 120.	30-120 days after COVID-19 diagnosis
Secondary	Number of patients with pulmonary-specific Post-COVID condition (PCC) up to 120 days after infection	Secondary endpoints will evaluate PCC by specific organ classes as defined by Xie et al. (doi:10.1001/jamainternmed.2023.0743). All patients are required to have a diagnosis of COVID-19 (ICD-10-CM code = U07.1) as an index event for the subsequent evaluation of a pulmonary-specific (i.e., shortness of breath and/or cough) PCC episode. The first 30 days after the diagnosis of COVID-19 will be excluded from the evaluation of a PCC episode as the acute infection period. The evaluation of the pulmonary-specific PCC episode will begin on Day 31 after the date of COVID-19 diagnosis through day 120.	30-120 days after COVID-19 diagnosis

External Links

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