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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02385123
The ClinicalTrials.gov registry entry for NCT02385123 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 60 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 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Influenza Virus Vaccine Inactivated is the first listed.
NCT02385123 reports 0 study locations.
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.
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