- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00349037
Study of the Ability of a Flu Vaccine to Prevent Flu Infection
January 25, 2007 updated by: PowderMed
A Prospective, Randomised, Double Blind, Placebo-Controlled Study to Assess the Efficacy of a Trivalent (A/New Caledonia/20/99, A/Panama/2007/99, B/Jiangsu/10/20) DNA Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) Against a Controlled Influenza Virus Challenge.
The purpose of this study is to evaluate how effective the vaccine is at preventing subjects developing flu symptoms after they are directly exposed to flu virus.
The study will also evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Influenza is a contagious disease of the upper airways and the lungs.
It rapidly spreads around the world in seasonal epidemics, killing hundreds of thousands of people and having high economic consequences due to healthcare costs and lost productivity.
Each year governments recommend groups who are at risk of influenza or its complications to receive influenza vaccination.
Current vaccine supply is not sufficient to meet the demand if this recommendation were to be taken up by all.
This study will evaluate PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for influenza as a potential alternative to existing vaccine technologies.
This study will assess how effective two different PMED vaccine combinations are at preventing subjects developing influenza following exposure to flu virus 56 days after a single dose of vaccine.
Study Type
Interventional
Enrollment
105
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom
- GDRU Quintiles Ltd
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Healthy adult volunteers (women must be of non child-bearing potential)
Provided written informed consent
Exclusion Criteria:
No significant concomitant illness
No allergy to gold
No immunosuppression due to disease or treatment
Pre-existing protective level of antibody against the challenge virus strain
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Efficacy of the vaccine in preventing symptoms of influenza-like illness
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Secondary Outcome Measures
Outcome Measure |
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Safety and tolerability - AEs and laboratory tests. Immunogenicity of the vaccine
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tim Mant, BSc, FRCP, FFPM, GDRU
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Study Completion
January 1, 2007
Study Registration Dates
First Submitted
July 5, 2006
First Submitted That Met QC Criteria
July 5, 2006
First Posted (Estimate)
July 6, 2006
Study Record Updates
Last Update Posted (Estimate)
January 29, 2007
Last Update Submitted That Met QC Criteria
January 25, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PM FLS-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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