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

NCT01677676 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-07-29

No results posted yet for this study

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

Interventions

BIOLOGICAL

FP-01.1

IM injection

BIOLOGICAL

FP-01.1-Adjuvant

IM injection

Sponsors & Collaborators

  • INCResearch Australia Pty Limited

    collaborator UNKNOWN

  • Immune Targeting Systems Ltd

    lead INDUSTRY

Principal Investigators

  • Joanne Marjason · Q-Pharm Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-05-31
Completion
2012-09-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01677676 on ClinicalTrials.gov