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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00436046
The ClinicalTrials.gov registry entry for NCT00436046 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 95 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 2 interventions - of which Trivalent inactivated influenza virus vaccine (2006-2007 formulation) is the first listed.
NCT00436046 reports 0 study locations.
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.
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