Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05876377 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusTerminated
PhaseNot specified
SponsorPfizer
Started2023-10-23
View on ClinicalTrials.gov ↗
Why the trial stopped
Study discontinued due to questions of data validity and bias in data which would limit causal inference and estimation of vaccine effectiveness.

Amendment history

2026-09-16
Reclassified as terminated (was completed)
Trial terminated: Study discontinued due to questions of data validity and bias in data which would limit causal inference and estimation...
2026-06-29
Study Status v20
Trial completed
Completion moved earlier: 2026-09-30 → 2026-05-31
2026-03-11
Completed→Active, Not Recruiting Study Status, Study Description, Arms and Interventions, Eligibility v19
Trial statusCompleted→Active, Not Recruiting
Primary completion date2025-09-09→2026-05-31
Completion date2025-09-09→2026-09-30
Eligibility criteria+2 characters
[...] required to have a COVID-19 diagnosis on or after September 255, 20232024 AND no later than August 26, 2025 Patients in HealthVerity database and residing in Californi [...] m 1 year prior to cohort entry OR Patients who received any 20232024-2024 XBB-adapted2025 formulation of the COVID-19 vaccine prior to authorization (1122 SeptemberAugust 20232024) OR Patients who have discrepancies in sex and/or year of b [...] 80 days preceding cohort entry OR Patients who received any 2023-2024 XBB-adapted/2025 formulation of the COVID-19 vaccine within 0 to 13 days pri [...]
Study description-58 characters
The vaccine effectiveness (VE) of theBNT162b2 COVID-19 vaccine (e.g. KP.2 monovalent formulation) in preventing post-COVID health conditions will be assessed (Aim 1). ToThis doaim this,will utilize a retrospective cohort time-to-event design willand beevaluate employedthe VE among vaccine-eligible patients from when the vaccine was authorized or approved (specified by age group) through the most current data available. Patients will be observed until an endpoint (post-COVID related condition) or a censoring event (BNT162b2 vaccine, Other COVID-19 vaccinations formulated for 2023-2024 respirato [...] [...]
2025-11-04
Active, Not Recruiting→Completed Study Status v18
Trial statusActive, Not Recruiting→Completed
Primary completion dateestimated 2025-12-31→confirmed 2025-09-09
Completion dateestimated 2025-12-31→confirmed 2025-09-09
2025-09-08
3 amendments v15-v17
3 re-verifications since 2025-08-04, no change to tracked fields
Show 14 earlier versions
2025-07-15
Study Status, Study Description, Study Design, Arms and Interventions, Eligibility v14
Eligibility criteria+240 characters
Aim 1: Inclusion Criteria: Patients must meet all of the following criteria to be eligible for inclusion in the study: Patients are required to have a COVID-19 diagnosis on or after September 25, 2023 AND Patients in HealthVerity database and residing in California or Louisiana as of 25index September 2023date AND Have ≥1 year of pharmacy and medical enrollment in Heal [...] or up to a 30-day gap in enrollment AND ≥18 years old as of 11index September 2023date AND Have resided only in their respective state (California or Louisiana) for ≥1 year prior to 11index September 2023date Exclusion Criteria: [...] [...]
Study description+50 characters
[...] 9 vaccinations formulated for 2023-2024 respiratory season, or moderate/severe immunocompromised condition, or pregnancy). All eligible patients aremust consideredhave unvaccinatedbeen diagnosed with COVID-19 (unexposedindex event) at cohort entry at which point vaccination status is determined. Patients then continue to contribute person-time to the ti [...]
2025-07-08
4 amendments v10-v13
4 re-verifications since 2025-04-15, no change to tracked fields
2025-03-03
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v9
Eligibility criteria+2,766 characters
Aim 1: Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: IncludePatients patientsin whoseHealthVerity claims recordsdatabase and vaccine registry data are both availableresiding in theCalifornia or Louisiana as of 25 September 2023 AND Have ≥1 year of pharmacy and medical enrollment in HealthVerity databases Include patients who are eligibleprior to receivecohort theentry licensed/authorizeddate, vaccineallowing duringfor theup studyto perioda 30-day gap in enrollment AND ≥18 years old as of 11 September 2023 AND Have resi [...] [...]
Secondary endpoints-206 characters
Number of patients with cardiovascular-specific Post-COVID condition (PCC) up to 120 days after infection Number of patients with pulmonary-specific Post-COVID condition (PCC) up to 120 days after infection
Primary endpoints2 entries, revised
NumberAim of1: patientsAny withPCC-related Postdiagnosis not present before the COVID-COVID19 conditiondiagnosis Aim (PCC)2: up to 120 days after infection Number of patients with a COVID-19 vaccination
Study description+86 characters
We will assess theThe effectiveness of the COVID-19 vaccine in preventing post-vaccineCOVID health conditions will be assessed (Aim 1). To do this, wea retrospective cohort time-to-event design will employbe employed. Patients will be observed until an endpoint (post-COVID related condition) or a targetcensoring trialevent emulation(BNT162b2 designvaccine, examiningOther theCOVID-19 vaccine'svaccinations effectivenessformulated fromfor 2023-2024 respiratory season, moderate/severe immunocompromised condition, or pregnancy). All eligible patients are considered unvaccinated (unexposed) at cohor [...] [...]
2025-01-23
Study Status, Study Design v8
Re-verified, no change to tracked fields
2025-01-06
Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-12→2025-12-31
Completion date2024-12→2025-12-31
Enrollment target999→1
Study sitesdetails revised at 1 of 1 site
2024-12-16
Study Status v6
Primary completion date2024-10-31→2024-12
Completion date2024-10-31→2024-12
2024-09-30
Study Status v5
Primary completion date2024-08-30→2024-10-31
Completion date2024-08-30→2024-10-31
2024-05-31
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v4
InterventionsPfizer-BioNTech COVID-19 bivalent mRNA vaccine (Biological)→Pfizer-BioNTech COVID-19 mRNA vaccine (Biological)
Eligibility criteria+148 characters
[...] databases Include patients who are eligible to receive the bivalentlicensed/authorized boostervaccine 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 cr [...] will not be included in the study: Exclude patients with a PCCcondition episodeof interest prior to being eligible for the bivalent mRNA COVID-19 vaccine booster Receipt of the bivalent mRNA COVID-19 vaccine booster prior to date of licensure/authorization (i.e., September 11, 2023 for XBB formulation) E [...] [...]
Secondary endpoints12 to 2 entries
Number of patients with cardiovascular-specific Post-COVID condition (PCC) definedup usingto the120 ICD-10-CMdays codeafter infection Number of patients with PCC defined with a new pulmonary-specific condition Number of patients with a new PCC defined with commonly experienced diagnoses or symptoms Number of patients with PCC defined with a new diagnosis for a cardiovascularPost-COVID condition Number of(PCC) patientsup withto PCC120 defineddays withafter a new diagnosis for a hemolytic/vascular condition Number of patients with PCC defined with a diagnosis for a new pulmonary condition Number [...] [...]
Primary endpoints2 entries, revised
Number of patients with Post-COVID condition (PCC) definedup asto a120 compositedays ofafter 3 definitionsinfection Number of patients with ana mRNA bivalentCOVID-19 vaccination
Study description+1,502 characters
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 mo [...]
Study title-4 characters
EffectivenessUse and UseEffectiveness of COVID-19 Vaccines Using Information From the California State Vaccine RegistryRegistries and Insurance Claims Data
2024-02-16
Study Identification, Study Status v3
Re-verified, no change to tracked fields
2023-11-13
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Design, Eligibility, Contacts/Locations, References v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-10-31→2024-08-30
Completion date2023-10-31→2024-08-30
Start dateestimated 2023-09-15→confirmed 2023-10-23
Enrollment target18000000→999
Study sites0→1
2023-09-13
Study Status v1
Primary completion date2023-08-31→2023-10-31
Completion date2023-08-31→2023-10-31
Start date2023-06-05→2023-09-15
2023-05-23
Original filing
Pfizer
431 trials monitored
See 32 trials at risk
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.
Trial Details
NCT Number NCT05876377
Lead Sponsor Pfizer
Conditions SARS-CoV-2, COVID-19, Post-Acute COVID-19 Syndrome
Enrollment 1 participants
Start Date 2023-10-23
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-15