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NCT04044352 · ClinicalTrials.gov registry record · Phase 1
H1N1v Virus Challenge Study in Healthy Subjects
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
NCT04044352 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 76 participants.
The verdict
NCT04044352, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
Study Summary
This is a study of a reverse-engineered, Good Manufacturing Practice (GMP) grade, antiviral-sensitive, influenza A/Bethesda/MM2/H1N1 virus (A/California/04/2009/H1N1-like) infection to assess the effect of pre-existing immunity on clinical and immunological responses. Up to 80 healthy adult subjects will undergo intranasal inoculation with A/Bethesda/MM2/H1N1 virus, and their clinical manifestations, viral shedding and immunological responses will be characterized. The Primary Objective for this study is to evaluate the association of symptomatic Reverse Transcription-Polymerase Chain Reaction (RT-PCR)-positive influenza virus infection post-challenge and pre-existing Hemagglutinin Inhibition Test (HAI) antibody titers.
Interventions
- BIOLOGICAL Influenza A/Bethesda/MM2/H1N1 Challenge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2019-10-22 |
| Est. Completion | 2020-03-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04044352
The ClinicalTrials.gov registry entry for NCT04044352 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 76 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 A/Bethesda/MM2/H1N1 Challenge is the first listed.
NCT04044352 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04044352 about?
NCT04044352 is a clinical study titled "H1N1v Virus Challenge Study in Healthy Subjects". This is a study of a reverse-engineered, Good Manufacturing Practice (GMP) grade, antiviral-sensitive, influenza A/Bethesda/MM2/H1N1 virus (A/California/04/2009/H1N1-like) infection to assess the effect of pre-existing immunity on clinical and immunological responses. Up to 80 healthy adult subjects...
What is the current status of trial NCT04044352?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2019-10-22. Estimated completion is 2020-03-02.
What interventions are being tested in trial NCT04044352?
The interventions under investigation include: Influenza A/Bethesda/MM2/H1N1 Challenge (BIOLOGICAL).
Who is sponsoring clinical trial NCT04044352?
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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