Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study of Healthy Volunteer, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Change in antibody titer response to vaccination, as measured by microneutralization titers at day 0 and day 70 and its relationship with novel baseline biomarkers
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 |
What the finished NCT04025580 record still lists
NCT04025580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (51% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy Volunteer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04025580's enrollment target sits among peer trials
98 34th of 112 higher than 79 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Early Metabolic Effects of Dolutegravir or Tenofovir Alefenamide in Healthy Volunteers
RECRUITING · Phase 2
-
Ultralow Dose PET Imaging of 18F-Florbetapir, 18F-Flutemetamol
RECRUITING · Phase 2
-
Ultralow Dose PET Imaging of 18F-FDG Uptake
RECRUITING · Phase 2
-
Ultralow Dose PET Imaging for 18F-NaF Uptake
RECRUITING · Phase 2
-
Ultralow Dose PET Imaging for PSMA Expression
RECRUITING · Phase 2
-
Healthy Volunteer Study
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02926729 · 98 participants · NA
Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
- NCT03382977 · 98 participants · Phase 1
Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects
- NCT04577014 · 98 participants · Phase 1
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
- NCT04817618 · 98 participants · Phase 3
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI