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NCT02385123 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Human Immune Responses to Influenza Virus Vaccination in Healthy Volunteers
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT02385123: Clinical Trial Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02385123 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 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02385123, 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
- 60 participants
- Enrollment target
Study Summary
This was an open label, single arm, Phase IV study of longitudinal immunologic responses to influenza vaccine in healthy adult participants, with the aim of enrolling up to 70 participants. This study enrolled males and non-pregnant females, 18-49 years old, inclusive. The participants were screened at enrollment with a history and physical exam and laboratory testing to ensure they were healthy enough to participate. Total enrollment was 60 participants. Qualifying participants were vaccinated with an FDA approved seasonal inactivated influenza vaccine (IIV) according to the package insert. The study enrolled a total 60 participants. The primary objective of the study was to characterize HA-specific plasmablasts and memory B cells after influenza vaccination. Note: Due to the Coronavirus Disease 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. Five participants had their Day 180 visits halted due to the COVID-19 pandemic.
Primary Outcome
Hemagglutination inhibition titers were measured against reference influenza A/H1N1 and A/H3N2 strains, as well as influenza B Yamagata lineage influenza strains. Strains were matched to the composition of the vaccine received by each subject. For H1N1 and H3N2, hemagglutination was performed using receptor destroying enzyme (RDE)-treated plasma and turkey red blood cells following the World Health Organization (WHO) standard protocol. For influenza B, guinea pig red blood cells were used instea
Interventions
- BIOLOGICAL Influenza Virus Vaccine Inactivated
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2015-04-01 |
| Est. Completion | 2020-12-31 |
| Phase | Phase 4 |
Why NCT02385123 stopped before completion
NCT02385123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Influenza Virus Vaccine Inactivated is the first listed.
NCT02385123 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02385123 about?
NCT02385123 is a clinical study titled "Evaluation of Human Immune Responses to Influenza Virus Vaccination in Healthy Volunteers". This was an open label, single arm, Phase IV study of longitudinal immunologic responses to influenza vaccine in healthy adult participants, with the aim of enrolling up to 70 participants. This study enrolled males and non-pregnant females, 18-49 years old, inclusive. The participants were screened...
What is the current status of trial NCT02385123?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2015-04-01. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT02385123?
The interventions under investigation include: Influenza Virus Vaccine Inactivated (BIOLOGICAL).
Who is sponsoring clinical trial NCT02385123?
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 NCT02385123's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 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
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