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NCT00436046 · ClinicalTrials.gov registry record · Phase 1
Interferon as a Mucosal Adjuvant for Influenza Vaccine Given Intranasally
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
NCT00436046: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00436046 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 95 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00436046, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
Study Summary
Influenza is a virus infection that causes sickness from the nose to the lungs. It is thought that type 1 interferon (a protein that helps the immune system fight viruses) will make flu vaccines more effective. This study will determine if type 1 interferon added to a specific flu vaccine will help the immune system of healthy adults fight off infection better than vaccine alone. Ninety volunteers, ages 18-40, will participate in this study. They will attend 3 study visits and have a final follow-up study visit, email, or phone call about six months after the vaccination. Volunteers will receive a single dose of study vaccine sprayed into the nose. Study procedures including blood samples and nasal washes (the inside of the nose is washed out) will be collected to evaluate immune system responses.
Primary Outcome
Number of subjects (frequency) responding with a four-fold or greater increase (magnitude) in titer at day 14 after immunization, relative to pre-immunization levels
Interventions
- BIOLOGICAL Trivalent inactivated influenza virus vaccine (2006-2007 formulation)
- BIOLOGICAL Type 1 interferon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2007-03 |
| Est. Completion | 2007-10 |
| Phase | Phase 1 |
What the finished NCT00436046 record still lists
NCT00436046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 2 interventions - of which Trivalent inactivated influenza virus vaccine (2006-2007 formulation) is the first listed.
NCT00436046 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00436046 about?
NCT00436046 is a clinical study titled "Interferon as a Mucosal Adjuvant for Influenza Vaccine Given Intranasally". Influenza is a virus infection that causes sickness from the nose to the lungs. It is thought that type 1 interferon (a protein that helps the immune system fight viruses) will make flu vaccines more effective. This study will determine if type 1 interferon added to a specific flu vaccine will help ...
What is the current status of trial NCT00436046?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2007-03. Estimated completion is 2007-10.
What interventions are being tested in trial NCT00436046?
The interventions under investigation include: Trivalent inactivated influenza virus vaccine (2006-2007 formulation) (BIOLOGICAL), Type 1 interferon (BIOLOGICAL).
Who is sponsoring clinical trial NCT00436046?
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 NCT00436046's enrollment target sits among peer trials
95 610th of 2000 higher than 1,386 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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