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NCT01258062 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Safety of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults
A Phase 1 study, sponsored by Alachua Government Services.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT01258062 is a Phase 1 study that has completed, run by Alachua Government Services. The registered enrollment target is 7 participants.
The verdict
NCT01258062, a Phase 1 study, has completed, sponsored by Alachua Government Services.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of age who are eligible for study participation will be enrolled in the trial. It is expected that 10 subjects will be screened to obtain 7 subjects who will be eligible for study participation. The primary objective is to determine the frequency and severity of local and systemic adverse events of vaccine. The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI, serum neutralizing, and nasal wash IgA antibodies.
Interventions
- DRUG Placebo
- DRUG GelVac™ nasal powder H5N1 influenza vaccine.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01258062
The ClinicalTrials.gov registry entry for NCT01258062 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alachua Government Services, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01258062 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01258062 about?
NCT01258062 is a clinical study titled "Study to Assess Safety of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults". This is a double-blind, placebo controlled, safety and immunogenicity study of GelVac™ nasal powder H5N1 influenza vaccine. Healthy male and female subjects between 18 and 49 years of age who are eligible for study participation will be enrolled in the trial. It is expected that 10 subjects will be ...
What is the current status of trial NCT01258062?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2010-09. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01258062?
The interventions under investigation include: Placebo (DRUG), GelVac™ nasal powder H5N1 influenza vaccine. (DRUG).
Who is sponsoring clinical trial NCT01258062?
This trial is sponsored by Alachua Government Services, which has 12 total clinical trials registered on ClinicalTrials.gov.
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