Study to Assess Safety of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults
Public ClinicalTrials.gov record NCT01258062. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1, Double Blind, Randomized, Placebo Controlled Study to Assess Safety and Immunogenicity of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01258062
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 7 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2010
- Primary completion
- Mar 31, 2011
- Completion
- Mar 31, 2011
- Last update posted
- Feb 1, 2017
2010 – 2011
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Florida Research Network, LLC | Gainesville | Florida | 32605 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01258062, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 1, 2017 · Synced Sep 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01258062 live on ClinicalTrials.gov.