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Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu

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. Identifier: NCT00347529
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : January 29, 2007
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Brief Summary:
The purpose of this study is to 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 that may protect against the subjects catching a pandemic strain of flu

Condition or disease Intervention/treatment Phase
Influenza (Pandemic) Biological: pPML7789 with and without pPJV2012 administered by PMED Phase 1

Detailed Description:
Pandemic influenza occurs when a strain of influenza to which the human population has not been exposed develops the ability to infect man and spread from person to person. Some pandemics can have very severe health impacts and be widespread. This study will evaluate PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for pandemic influenza as a potential alternative to other vaccine technologies. This study represents the first study with this vaccine and will provisionally assess its safety and immunogenicity (ability to generate an immune response) at four different dose combinations. The vaccine will be given as a prime-boost regimen with vaccination on Days 0 and 28

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Study Type : Interventional  (Clinical Trial)
Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomised Double Blind Dose-Ranging Study to Assess the Safety, Tolerability and Immunogenicity of a Monovalent H5 DNA Influenza Vaccine (A Vietnam/1194/2004) Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Adults
Study Start Date : August 2006
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Primary Outcome Measures :
  1. Safety, tolerability and local reactogenicity-AEs and laboratory parameters.

Secondary Outcome Measures :
  1. 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.

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

Inclusion Criteria:

Healthy adults volunteers (women must be of nonchild-bearing potential) Provided written informed consent


Exclusion Criteria:

No significant concomitant illness No allergy to gold No immunosuppression due to disease or treatment

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 identifier (NCT number): NCT00347529

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United Kingdom
Guys Research Drug Unit, Quintiles Ltd.
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
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Principal Investigator: Tim Mant, BSc, FRCP, FFPM Guys Research Drug Unit, Quintiles UK Ltd.

Layout table for additonal information Identifier: NCT00347529     History of Changes
Other Study ID Numbers: PM FLP-001
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: January 29, 2007
Last Verified: January 2007
Keywords provided by PowderMed:
DNA vaccine, influenza, immunogenicity, tolerability, PMED, pandemic
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs