Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine
NCT04025580 · View on ClinicalTrials.gov ↗
Study Summary
Background: Vaccines help prevent disease by causing the body to have an immune response. Many parts of this response happen in the blood. This response happens over days and weeks after getting the vaccine. Researchers want to how the blood changes over time in response to vaccines. They want to find out why vaccines work better for some people than for others. This could help make more effective vaccines. Objective: To learn about how the body responds to vaccines. Eligibility: Healthy people ages 18 and older Design: Participants will be screened with a medical history, physical exam, and blood and urine tests. Participants will have 9 visits over 6 months. All visits will include blood tests and a physical exam. Participants will have the first visit 1 week before they get the vaccine. Participants will get the flu vaccine at the second visit. The vaccine will be injected into the muscle of the upper arm with a needle. They will be watched for side effects for 15 minutes. Participants will have the next 2 visits exactly 1 day and 1 week after they get the vaccine. They will have the other 5 visits about 14, 28, 70, and 100 days after they get the vaccine. Participants will take email questionnaires about whether they had any side effects. Participants may have optional extra study visits. These will be no more than once a month for up to 1 year after they get the vaccine. Optionally, they can also repeat the study each year through the 2023 - 2024 flu season
Conditions Studied
Interventions
- BIOLOGICAL Flucelvax
- BIOLOGICAL Fluvirin
- BIOLOGICAL Fluzone High Dose
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2019-10-02 |
| Est. Completion | 2023-01-31 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04025580
The ClinicalTrials.gov registry entry for NCT04025580 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 3 interventions — of which Flucelvax is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04025580 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04025580 about?
NCT04025580 is a clinical study titled "Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine". Background: Vaccines help prevent disease by causing the body to have an immune response. Many parts of this response happen in the blood. This response happens over days and weeks after getting the vaccine. Researchers want to how the blood changes over time in response to vaccines. They want to f...
What is the current status of trial NCT04025580?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2019-10-02. Estimated completion is 2023-01-31.
What conditions does trial NCT04025580 study?
This clinical trial studies the following conditions: Healthy Volunteer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04025580?
The interventions under investigation include: Flucelvax (BIOLOGICAL), Fluvirin (BIOLOGICAL), Fluzone High Dose (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04025580?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04025580 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.