NCT03926416

Safety Study of Live Attenuated Influenza Vaccine, CodaVax

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 125 (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 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).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	CodaVax-H1N1	Live-attenuated vaccine against influenza A H1N1, A/California/07/2009
BIOLOGICAL	Fluzone quadrivalent	Fluzone® (QuadriFlu - TIV), inactivated, quadrivalent influenza vaccine

Timeline

• Start date: 2017-02-21
• Primary completion: 2018-05-29
• Completion: 2018-09-14
• First posted: 2019-04-24
• Last updated: 2020-07-23

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study