Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347529
Status:
COMPLETED
Last Update Posted:
2007-01-29
First Post:
2006-06-30
Brief Title:
Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu
Sponsor:
PowderMed
Organization:
PowderMed
Study Overview
Official Title:
A Randomised Double Blind Dose-Ranging Study to Assess the Safety Tolerability and Immunogenicity of a Monovalent H5 DNA Influenza Vaccine A Vietnam11942004 Administered by Particle Mediated Epidermal Delivery PMED to Healthy Adults
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 PowderMeds 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None