A Phase III Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (Oka/Merck) in Patients on Chronic/Maintenance Corticosteroids
- Conditions
- The objective of the study is to evaluate the general safety of ZOSTAVAX™ in subjects on Chronic/Maintenance cortosteroid therapy.MedDRA version: 8.1 Level: LLT Classification code 10019974 Term: Herpes zoster
- Registration Number
- EUCTR2006-003651-20-FR
- Lead Sponsor
- aboratoires Merck Sharp & Dohme - Chibret
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
1. Age=60 years.
2. A history of varicella or long-term residence in a country with endemic VZV infection.
3. Receiving chronic/maintenance systemic corticosteroid therapy at a daily dose equivalent of 5 to 20 mg of prednisone during the 8 weeks immediately prior to enrolment.
4. Expected to continue to receive a daily dose of 5 to 20 mg of prednisone or equivalent for the 6-week duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Prior history of HZ
2. Prior receipt of any varicella or zoster vaccine.
3. Any use in the 8 weeks prior to vaccination or for 6 weeks postvaccination of concomitant immunosuppressive medications (e.g. corticosteroids >20 mg daily, chemotherapeutic agents, immunomodulating drugs, immunosuppressive treatments associated with solid organ or bone marrow transplantation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: Main objective: To determine whether ZOSTAVAX™ [zoster vaccine live (Oka/Merck)] is well tolerated when administered to patients who are receiving chronic/maintenance corticosteroid therapy.<br><br> ;<br> Secondary Objective: Secondary objective: To determine whether ZOSTAVAX™ [zoster vaccine live (Oka/Merck)] is immunogenic when administered to patients who are receiving chronic/maintenance corticosteroid therapy.<br> ;Primary end point(s): Number of patients with generalized vacin-strain VZV-like with 25 or more lesions during the 42-day postvaccination safety follow-up period.
- Secondary Outcome Measures
Name Time Method