Covid19 Clinical Trial - Use & Effectiveness of COVID-19 Vaccines Using

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05876377
Study type	Observational
Source	Pfizer
Contact	Pfizer CT.gov Call Center
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com
Status	Recruiting
Phase
Start date	October 23, 2023
Completion date	August 30, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms