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Study to Assess Safety of an Inactivated H5N1 Influenza Vaccine Administered in GelVac Nasal Powder to Healthy Young Adults

NCT01258062 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-02-02

No results posted yet for this 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.

Conditions

  • Phase 1 Safety Study of GelVac Nasal Powder H5N1 Influenza Vaccine

Interventions

DRUG

GelVac™ nasal powder H5N1 influenza vaccine.

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

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

Sponsors & Collaborators

  • Alachua Government Services, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01258062 on ClinicalTrials.gov