Trials / Completed
CompletedNCT04146623
Safety Study of Live Attenuated Influenza Vaccine, CodaVax, Delivered Via Intranasal Spray
A Randomized Double-Blind, Placebo Controlled, Phase I Study of the Safety, Tolerability and Immunogenicity of a Live Attenuated H1N1 Vaccine in Healthy Individuals
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Codagenix, Inc · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This study is being conducted to assess the safety, tolerability, and immunogenicity of the live-attenuated CodaVax-H1N1 influenza vaccine as compared to normal saline placebo both administered via intranasal spray to healthy adults.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CodaVax-H1N1 influenza vaccine | CodaVax-H1N1, a live attenuated vaccine (LAIV) strain based on the A/California/07/2009 (H1N1) influenza virus, administered once intranasally via a sprayer at a dose of 8 x10\^5 plaque forming units (PFU). |
| BIOLOGICAL | Normal Saline Placebo | Saline (0.9%) administered intranasally via sprayer |
Timeline
- Start date
- 2019-05-07
- Primary completion
- 2020-10-11
- Completion
- 2020-11-11
- First posted
- 2019-10-31
- Last updated
- 2020-12-01
Locations
1 site across 1 country: Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04146623. Inclusion in this directory is not an endorsement.