Influenza Clinical Trial
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.
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
Status | Completed |
Enrollment | 105 |
Est. completion date | January 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | GDRU Quintiles Ltd | London |
Lead Sponsor | Collaborator |
---|---|
PowderMed |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of the vaccine in preventing symptoms of influenza-like illness | |||
Secondary | Safety and tolerability - AEs and laboratory tests. Immunogenicity of the vaccine |
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