Clinical Trial: A Randomized Phase II Trial to Compare the Safety and Neutralizing Activity of CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Single-blind, Controlled, Monocentric Phase II Trial to Compare the Safety and Neutralizing Activity of Simulated Rabies Post-exposure Prophylaxis With CL184
Brief Summary: The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) or placebo in combination with rabies vaccine in healthy adult subjects.
Detailed Summary:
Sponsor: Crucell Holland BV
Current Primary Outcome: Safety and tolerability [ Time Frame: 42 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Rabies virus neutralizing activity [ Time Frame: 42 days ]
Original Secondary Outcome: Same as current
Information By: Crucell Holland BV
Dates:
Date Received: April 4, 2008
Date Started: March 2008
Date Completion:
Last Updated: September 15, 2011
Last Verified: September 2011