A Phase 1 interventional study of GelVac™ nasal powder H5N1 influenza vaccine. and Placebo in Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza Vaccine, sponsored by Resilience Government Services, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-02.
Sponsored by Resilience Government Services, Inc. · Phase 1, Interventional, and Prevention
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 7 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Resilience Government Services, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: GelVac™ nasal powder H5N1 influenza vaccine.
Drug: Placebo
subjects will be randomized to either 30 µg of Inactivated H5N1 Influenza Vaccine Administered in GelVac™ Nasal Powder given as two doses of 15 μg in one nostril or placebo vaccine given as two doses administered in GelVac™ Nasal Powder in one nostril
subjects will be randomized to either 30 µg of Inactivated H5N1 Influenza Vaccine Administered in GelVac™ Nasal Powder given as two doses of 15 μg in one nostril or placebo vaccine given as two doses administered in GelVac™ Nasal Powder in one nostril
The primary objective is to determine the frequency of adverse events of the vaccine.
Time frame: up to 26 weeks
The secondary objective is to assess the immunogenicity of the vaccine based on geometric mean titers (GMT) of serum HAI.
Time frame: up to 26 weeks
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Resilience Government Services, Inc.