drugset / Trial / NCT01354379
Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008 Administered by Sprayer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.