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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05876377




Registration number
NCT05876377
Ethics application status
Date submitted
23/05/2023
Date registered
25/05/2023

Titles & IDs
Public title
Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data
Scientific title
Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data
Secondary ID [1] 0 0
C4591059
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 0 0
COVID-19 0 0
Post-Acute COVID-19 Syndrome 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - Pfizer-BioNTech COVID-19 mRNA vaccine

Patient had Pfizer-BioNTech COVID-19 mRNA vaccine of interest - Patient identified in the vaccine registry having one or more dose of Pfizer-BioNTech COVID-19 mRNA vaccine of interest

Patient did not have a Pfizer-BioNTech COVID-19 mRNA vaccine of interest - Patient not located in the vaccine registry having one or more dose of Pfizer-BioNTech COVID-19 mRNA vaccine of interest


Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with Post-COVID condition (PCC) up to 120 days after infection
Timepoint [1] 0 0
30-120 days after COVID-19 diagnosis
Primary outcome [2] 0 0
Number of patients with a COVID-19 vaccination
Timepoint [2] 0 0
Date of vaccine authorization through the end of the corresponding respiratory season
Secondary outcome [1] 0 0
Number of patients with cardiovascular-specific Post-COVID condition (PCC) up to 120 days after infection
Timepoint [1] 0 0
30-120 days after COVID-19 diagnosis
Secondary outcome [2] 0 0
Number of patients with pulmonary-specific Post-COVID condition (PCC) up to 120 days after infection
Timepoint [2] 0 0
30-120 days after COVID-19 diagnosis

Eligibility
Key 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
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
999
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05876377