Trial intelligence / Profile preview

Safety and Neutralizing Activity of CL184 with Rabies Vaccine in Healthy Adults

NCT00656097Phase 2

Key facts

Status
Completed
Start
Mar 2008
Primary completion
Jul 2008
Countries
1
Sponsor
Crucell
Modality
Monoclonal Antibodies
Drugs
CL184
Conditions
rabies
01

Overview

Phase 2, randomised, single-blind trial of CL184 in rabies (3 arms), sponsored by Crucell. Primary endpoint: Safety and tolerability at 42 days. Started Mar 2008; status: completed.

02

Design

3 arms
Study design
RandomizedSingle-blind
  • CL184 + Vaccine

    CL184 (20 IU/kg) on Day 0 + Rabies Vaccine on Days 0, 3, 7, 14, 28

  • HRIG + Vaccine

    HRIG (20 IU/kg) on Day 0 + Rabies Vaccine on Days 0, 3, 7, 14, 28

  • Placebo + Vaccine

    Placebo on Day 0 + Rabies Vaccine on Days 0, 3, 7, 14, 28

03

Who it enrols

Healthy adults aged 19-65 with no prior rabies immunization and no significant health issues.

04

Endpoints

Primary

  • Safety and tolerability

Secondary

  • Rabies virus neutralizing activity

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