NCT01677676

Safety, Tolerability and Immunogenicity of Two Different Formulations of an Influenza A Vaccine (FP-01.1)

A Randomised, Double-Blind, Double Observer, Study to Assess the Safety, Tolerability and Immunogenicity of Repeated Intramuscular Administration of Two Different Formulations of an Influenza A Vaccine (FP-01.1)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Immune Targeting Systems Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study has been designed to evaluate the safety and immunogenicity of two different formulations of FP-01.1 as well as build on the data set from the first in human study FP-01.1\_CS\_01. It is anticipated that the results of this Phase I study will inform the best formulation of the vaccine to evaluate in efficacy studies.

Conditions

• Influenza A

Interventions

Type	Name	Description
BIOLOGICAL	FP-01.1	IM injection
BIOLOGICAL	FP-01.1-Adjuvant	IM injection

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-05-01
• Completion: 2012-09-01
• First posted: 2012-09-03
• Last updated: 2013-07-29

Locations

1 site across 1 country: Australia