Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02485639 · ClinicalTrials.gov registry record · Phase 4
Analysis of Bone Marrow and Blood B Cell Immune Responses to Influenza Vaccination
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 4
- Development phase
- 27
- Enrollment target
NCT02485639: Clinical Trial Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02485639 is a Phase 4 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 27 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02485639, a Phase 4 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 27 participants
- Enrollment target
Study Summary
This was a Phase IV open label and single arm study, with the aim of enrolling up to 55 healthy males and non-pregnant females in a single site, age 18-49 years old, inclusive. This study was designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to influenza vaccination in healthy adults. Total enrollment was 27 participants. This was a multi-year study. After one year of participation, participants were offered the opportunity to participate in the study for up to 3 consecutive years, provided eligibility criteria was met each year. Participants who elected to continue in the study after first year of participation were rescreened to verify continued eligibility and re-consented prior to subsequent participation. The primary study objective was to investigate the longevity of humoral immunity to influenza virus in humans. Note: Due to the Coronavirus Disease of 2019 (COVID-19) pandemic, all non-essential research was halted in mid-March 2020. New enrollments were placed on hold for this study. Follow-up visits were also halted, which impacted the timing of participants' subsequent follow-up visits. Participant visits for Day 7 and Day 14 were not impacted. For this study, there were participants whose Day 28 and Day 90 visits were impacted by the temporary halting of non-essential research studies. As such, a request was submitted to the Emory University Institutional Review Board to extend the missed visit windows for the Day 28 and Day 90 visits for a maximum of up to 180 days, to ensure that ample time was available to bring participants back for their missed visits. Enrollment for this study ended on March 31, 2020, before research activities could resume at Emory.
Primary Outcome
Blood Immunoglobulin G (IgG) ASC specific for the seasonal influenza vaccine were measured by enzyme-linked immunosorbent spot (ELISPOT) using vaccine-coated plates. Numbers of influenza-specific ASC per million peripheral blood mononuclear cells are reported.
Interventions
- BIOLOGICAL Influenza Virus Vaccine Inactivated
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2015-12-23 |
| Est. Completion | 2020-03-31 |
| Phase | Phase 4 |
Why NCT02485639 stopped before completion
NCT02485639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Influenza Virus Vaccine Inactivated is the first listed.
NCT02485639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02485639 about?
NCT02485639 is a clinical study titled "Analysis of Bone Marrow and Blood B Cell Immune Responses to Influenza Vaccination". This was a Phase IV open label and single arm study, with the aim of enrolling up to 55 healthy males and non-pregnant females in a single site, age 18-49 years old, inclusive. This study was designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to in...
What is the current status of trial NCT02485639?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2015-12-23. Estimated completion is 2020-03-31.
What interventions are being tested in trial NCT02485639?
The interventions under investigation include: Influenza Virus Vaccine Inactivated (BIOLOGICAL).
Who is sponsoring clinical trial NCT02485639?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02485639's enrollment target sits among peer trials
27 1651st of 2000 higher than 346 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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
- NCT00912041 · 27 participants · NA
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
- NCT02847559 · 27 participants · Phase 2
Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma
- NCT03380195 · 27 participants · NA
Effects of Watermelon Juice on Heart Rate Recovery and Post-exercise Muscle Soreness
- NCT03384238 · 27 participants · Phase 1
Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
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