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NCT02594189 · ClinicalTrials.gov registry record · Phase 1
Influenza A H3N2 Human Challenge Study in Healthy Adult Volunteers
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT02594189: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02594189 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02594189, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
Background: Influenza A H3N2 is a flu virus. Symptoms include fever, cough, and runny nose. It can also be more serious. Researchers want to know more about how influenza causes disease in people. They hope to develop new vaccines and treatments for flu infection. Objective: To find the smallest amount of Influenza A H3N2 virus that causes a mild to moderate flu infection in healthy people. Also, to study the body s immune response to this virus and how the infection develops. Eligibility: Healthy people ages 18 50 who are: Non-smokers or non-habitual smokers Willing to not smoke for at least 9 days Design: Participants will be screened under NIAID protocol #11-I-0183 Participants will stay at an isolation unit at the clinic for at least 9 days. They will remain in the isolation unit except for study-specific activities. The influenza virus will be sprayed into the nose. Participants will be monitored 24 hours a day. They will have tests, including: Medical history Physical exam Daily questionnaires about symptoms Blood and urine tests Nasal wash and swab: A small tube of salt water is placed in the nose to wash it. It then collects the fluid. Or the inside of the nose is rubbed with a swab. ECG: Measures the heart s electrical signals ECHO: Sound waves take pictures of the heart PFTs/Spirometry: They will blow into a machine that measures the air they blow. Participants will be discharged after they test negative for influenza A. Participants will return to the clinic for 4 follow-up visits over 8 weeks. They may complete questionnaires at home.
Interventions
- OTHER Live recombinantly derived A/Bethesda/MM1/H3N2 virus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2015-10-31 |
| Est. Completion | 2017-11-01 |
| Phase | Phase 1 |
What the finished NCT02594189 record still lists
NCT02594189 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 1 intervention - of which Live recombinantly derived A/Bethesda/MM1/H3N2 virus is the first listed.
NCT02594189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02594189 about?
NCT02594189 is a clinical study titled "Influenza A H3N2 Human Challenge Study in Healthy Adult Volunteers". Background: Influenza A H3N2 is a flu virus. Symptoms include fever, cough, and runny nose. It can also be more serious. Researchers want to know more about how influenza causes disease in people. They hope to develop new vaccines and treatments for flu infection. Objective: To find the smallest ...
What is the current status of trial NCT02594189?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2015-10-31. Estimated completion is 2017-11-01.
What interventions are being tested in trial NCT02594189?
The interventions under investigation include: Live recombinantly derived A/Bethesda/MM1/H3N2 virus (OTHER).
Who is sponsoring clinical trial NCT02594189?
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 NCT02594189's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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