Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375206
Status:
COMPLETED
Last Update Posted:
2007-01-29
First Post:
2006-09-11
Brief Title:
A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine
Sponsor:
PowderMed
Organization:
PowderMed
Study Overview
Official Title:
A Phase I Study to Assess Safety Tolerability and Immunogenicity of a Trivalent Influenza Vaccine Administered by Particle Mediated Epidermal Delivery PMED to Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 and any effects it may have on subjects wellbeing The study will also test the ability of vaccine to cause particular immune responses in the body
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 is part of the clinical development of a particle mediated epidermal delivery PMED trivalent DNA vaccine for the prevention of influenzaThis study will investigate the safety and tolerability of this vaccine as well as assess the humoral and cellular immunogenicity of the vaccine in healthy subjects
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