Status:
COMPLETED
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
Lead Sponsor:
Crucell Holland BV
Conditions:
Rabies
Eligibility:
All Genders
19-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Subjects free of obvious health-problems or with stable condition
- Male or female subjects aged ≥19 to ≤65 years
- BMI between ≥18 and ≤30 kg/m2
Exclusion
- Prior history of active or passive rabies immunization
- Clinically significant acute illness or infection within 2 weeks before first dosing based on the clinical judgment of the investigator
- History and/or family history of clinically significant immunodeficiency or auto-immune disease
- Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00656097
Start Date
March 1 2008
End Date
July 1 2008
Last Update
September 21 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
MDS Pharma Services , USA
Lincoln, Nebraska, United States, 68502