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NCT04025580 · ClinicalTrials.gov registry record · Phase 2
Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine
A Phase 2 study of Healthy Volunteer, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
- 1
- Study location
NCT04025580 is a Phase 2 study of Healthy Volunteer that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 98 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04025580, a Phase 2 study of Healthy Volunteer, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
- 1
- Study location
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?
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, categorized as Phase 2. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (51% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
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.
NCT04025580 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
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.
What interventions are being tested in trial NCT04025580?
The interventions under investigation include: Flucelvax (BIOLOGICAL), Fluvirin (BIOLOGICAL), Fluzone High Dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT04025580?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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