Clinical Trial: Study Assessing Safety and Immunogenicity of IC43 Vaccination Against Pseudomonas Aeruginosa in Healthy Volunteers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Against Pseudomonas Aeruginosa in Healthy Volunteers
Brief Summary: The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and tolerability.
Detailed Summary: The study will be designed as a multi‐center, observer‐blinded, randomized, placebocontrolled phase 1 study in healthy adult subjects of 18 to 65 years of age. A total of 160 healthy male and female subjects is planned to be enrolled and randomized in five groups receiving different dosages and formulations of IC43 or placebo.
Sponsor: Valneva Austria GmbH
Current Primary Outcome:
- immunogenicity at day 14 [ Time Frame: see above ]
- rate of serious adverse events during vaccination period until 6 months after first vaccination [ Time Frame: see above ]
- safety laboratory parameters at intervals up to day 180 [ Time Frame: see above ]
- systemic and local tolerability at intervals up to day 180 [ Time Frame: see above ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- immunogenicity [ Time Frame: see above ]
- measurement of functional antibody induction [ Time Frame: see above ]
- measurement of antibody avidity on days 7 and 14 [ Time Frame: see above ]
- measurement of anti-histidine antibodies on days 7, 14, 90, and 180 [ Time Frame: see above ]
Original Secondary Outcome: Same as current
Information By: Valneva Austria GmbH
Dates:
Date Received: October 22, 2008
Date Started: September 2008
Date Completion:
Last Updated: October 18, 2012
Last Verified: October 2012
