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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rabies

In brief

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.

Key facts

Study ID

NCT00656097

Run by

Crucell Holland BV

People needed

140

Starts

2008-03-01

Expected to finish

2008-07-01

Last updated by the study team

2011-09-21

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MDS Pharma Services , USA — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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