We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Study of the Ability of a Flu Vaccine to Prevent Flu Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00349037
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : January 29, 2007
Information provided by:

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Influenza Biological: Trivalent DNA vaccine with and without pPJV2012 administered by PMED Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : September 2006
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Primary Outcome Measures :
  1. Efficacy of the vaccine in preventing symptoms of influenza-like illness

Secondary Outcome Measures :
  1. Safety and tolerability - AEs and laboratory tests. Immunogenicity of the vaccine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349037

Layout table for location information
United Kingdom
GDRU Quintiles Ltd
London, United Kingdom
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: Tim Mant, BSc, FRCP, FFPM GDRU
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00349037    
Other Study ID Numbers: PM FLS-002
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: January 29, 2007
Last Verified: January 2007
Keywords provided by PowderMed:
DNA vaccine
challenge virus
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases