Influenza Clinical Trial
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
Verified date | January 2007 |
Source | PowderMed |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 189 |
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 |
Ages Eligible for Study: - 18 Years - 50 Years - Genders Eligible for Study: Both - Accepts Healthy Volunteers Criteria 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 - No previous flu vaccination in 2005 or 2006 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Quintiles Lenexa (QLX) | Lenexa | Kansas |
United States | Biokinetic | Springfield | Missouri |
Lead Sponsor | Collaborator |
---|---|
PowderMed |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety, tolerability and local reactogenicity - AEs and laboratory parameters | |||
Secondary | Immunogenicity of the vaccine |
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