drugset / Trial / NCT01354379

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

NCT01354379

Phase 1 Completed 125 enrolled NanoBio Corporation
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2011-05
Primary completion
2012-06
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Influenza Virus Vaccine Vaccine 15 ug Intranasal
Comparator Influenza Virus Vaccine Vaccine 0.2 ml Intranasal
Subject NB-1008 Vaccine 15 ug Intranasal
Subject NB-1008 Vaccine 0.2 ml Intranasal
Subject NB-1008 Vaccine 0.4 ml Intranasal
Subject NB-1008 Vaccine 20 % Intranasal

Indications

No indication recorded.