Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT03926416
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2019-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Live Attenuated Influenza Vaccine, CodaVax
Sponsor:
Codagenix, Inc
Organization:
Study Overview
Official Title:
A Randomised, Double-Blind, Double-Dummy, Active and Placebo Controlled Phase I Trial of the Safety, Tolerability and Immunogenicity of the CodaVax Influenza Vaccine
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted to assess the safety, tolerability, and immunogenicity of the CodaVax-H1N1 influenza vaccine as compared to active and placebo controls when administered to healthy adults.
Detailed Description:
This randomized, double-blind, placebo and active controlled Phase I study is intended to study the effects of a live-attenuated vaccine against influenza A H1N1. Part 1 of this study will enroll 75 participants at a single site. Participants will be randomized in a 2:2:1 ratio to receive one dose each of either CodaVax-H1N1, FluZone quadrivalent, or placebo. This study is conducted during the influenza "off season" in Australia. Part 2 of the study will enroll an 50 additional participants randomized to receive either CodaVax-H1N1 at a higher dose or placebo (40:10).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: