MedTrace Logo

Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008 Administered by Sprayer

NCT01354379 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2013-03-28

No results posted yet for this study

Summary

The purpose of this study is to test the safety and immune response of a new intranasal vaccine against influenza, called NB-1008. The vaccine is composed of a licensed vaccine that is normally given as an injection, called Fluzone, and an adjuvant (additive that helps a vaccine work better), called W805EC. In a prior clinical study this vaccine showed promising results in terms of being well tolerated and eliciting mucosal and systemic immune responses after administration by a dropper. In this study NB-1008 is being administered by dropper as well as a nasal sprayer to determine if the sprayer further enhances the immune response.

Conditions

  • Healthy Adult Volunteers

Interventions

BIOLOGICAL

NB-1008

NB-1008 is composed of Fluzone containing 15 micrograms (mcg) of strain-specific hemagglutinin (HA) and 20% W805EC adjuvant.

BIOLOGICAL

Fluzone IN

The active control is Fluzone containing 15 micrograms (mcg) of strain-specific hemagglutinin (HA).

Sponsors & Collaborators

  • NanoBio Corporation

    lead INDUSTRY

Principal Investigators

  • Casey T Johnson, DO · Johnson County Clin-Trials

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-06-30
Completion
2012-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01354379 on ClinicalTrials.gov