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NCT00978120 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of an H1N1 Influenza Vaccine in People With Asthma
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 390
- Enrollment target
NCT00978120: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00978120 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 390 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (193% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00978120, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 390 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in people with asthma. The study will enroll 350, and possibly up to 400 healthy adults ages 12 and older with mild, moderate, or severe asthma. Participants will be randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 mcg of H1N1 vaccine; group 2 will receive 30 mcg of H1N1 vaccine given as two 15 mcg injections. Both groups will receive vaccine injections on days 0 and 21. Study procedures include: medical history, physical exam, spirometry, maintaining a memory aid and, and blood sample collection. Participants will be involved in study related procedures for approximately 7 months.
Primary Outcome
Percentage of participants with serious adverse events (SAEs) attributed to vaccination, as determined by site investigators at the time of reporting.
Interventions
- BIOLOGICAL H1N1 vaccine high dose
- BIOLOGICAL H1N1 vaccine low dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-09 |
| Phase | Phase 2 |
What the finished NCT00978120 record still lists
NCT00978120 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (193% higher).
The record links to 0 conditions, and to 2 interventions - of which H1N1 vaccine high dose is the first listed.
NCT00978120 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00978120 about?
NCT00978120 is a clinical study titled "Safety and Efficacy of an H1N1 Influenza Vaccine in People With Asthma". The purpose of this study is to assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in people with asthma. The study will enroll 350, and possibly up to 400 healthy adults ages 12 and older with mild, moderate, or severe asthma....
What is the current status of trial NCT00978120?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 390 participants. The study started on 2009-10. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00978120?
The interventions under investigation include: H1N1 vaccine high dose (BIOLOGICAL), H1N1 vaccine low dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT00978120?
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 NCT00978120's enrollment target sits among peer trials
390 106th of 2000 higher than 1,893 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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