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Completed Phase 4 Interventional Accepts healthy volunteers Results available

Immunogenicity of Influenza Vaccinations

ClinicalTrials.gov ID: NCT06518577

Public ClinicalTrials.gov record NCT06518577. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 2:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Measuring Immunity Against Circulating Influenza Viruses: Randomized Immunogenicity Study Among US Adults Aged 18-64 Years Comparing Two Approved Influenza Vaccines

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study is a randomized immunogenicity study in an enrolled cohort with active surveillance for influenza-like illness (ILI). During this study, participants will be randomly assigned to receive an approved cell culture-based influenza vaccine (Flucelvax®) versus a licensed comparator influenza vaccine (Flublok®). Blood samples from participants will be collected for measurement of biomarkers of immune response at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Participants will be asked if they wish to also provide saliva specimens at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Serum and peripheral blood mononuclear cells (PBMC) and plasma samples will be isolated from whole blood and tested for biomarkers of vaccine immunogenicity, and duration of antibody responses. Participants will receive electronic surveys via email or text message weekly asking about changes in health status and new ILI symptoms; those reporting illness may be asked to provide a respiratory swab for laboratory testing for influenza and other respiratory viruses and up to 2 additional blood draws (acute \[\<10 days after symptom onset\] and convalescent \[28 days after acute visit if lab-confirmed positive for influenza\]).

Study identification

NCT ID
NCT06518577
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Duke University
Other
Enrollment
606 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years to 64 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 8, 2024
Primary completion
Dec 8, 2024
Completion
Jun 3, 2025
Last update posted
Jul 27, 2026

2024 – 2025

United States locations

U.S. sites
7
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
Valleywise Health Comprehensive Health Center Phoenix Arizona 85008
ASU Biodesign Institute Tempe Arizona 85281
Centers for Disease Control and Prevention Atlanta Georgia 30333
Washington University IDCRU St Louis Missouri 63110
University Hospitals Cleveland Medical Center Cleveland Ohio 44106
VA Northeast Ohio Healthcare System (VANEOHS) Cleveland Ohio 44106
Department of Family Medicine, University of Pittsburgh School of Medicine Pittsburgh Pennsylvania 15260

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06518577, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 27, 2026 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06518577 live on ClinicalTrials.gov.

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