NCT01333462

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

A Phase 1 Randomized, Single-Blind, Controlled, Safety, Tolerability and Immunogenicity Study of Intranasal NB-1008 (Fluzone® + 60%W805EC) in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: NanoBio Corporation · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Adult Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	NB-1008	NB-1008 is composed of Fluzone containing 4 micrograms (mcg) or 10 micrograms of strain-specific hemagglutinin (HA) and 5%, 10%, 15%, or 20% W805EC adjuvant.
OTHER	Control	The controls include PBS placebo control as well as Fluzone IN and IM active controls.

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-08-01
• Completion: 2010-09-01
• First posted: 2011-04-12
• Last updated: 2011-04-12

Locations

1 site across 1 country: United States