A Phase III Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (Oka/Merck) in Patients on Chronic/Maintenance Corticosteroids - Study of Zoster vaccine in subjects on chronic steroid maintenance

• Conditions: Zoster Vaccine; MedDRA version: 8.1Level: LLTClassification code 10019974Term: Herpes zoster

• Registration Number: EUCTR2006-003651-20-DE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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
Main Objective: Main objective: To determine whether ZOSTAVAX™ [zoster vaccine live (Oka/Merck)] has an acceptable safety profile when administered to patients who are receiving chromic/maintenance corticosteroid therapy.;Secondary Objective: Secondary objective: To evaluate the safety profile of ZOSTAVAX™ for noninjection-site VZV-like rashes during the 42-day safety follow-up period among ZOSTAVAX™ recipients on chronic/maintenance doses of corticosteroids. <br><br>Tertiary objective: To evaluate the safety profile of ZOSTAVAX™ for serious adverse experiences during the 6-month safety follow-up period among patients on chronic/maintenance doses of corticosteroids.;Primary end point(s): The number of patients with generalized vaccine-strain VZV-like rashes with 25 or more lesions during the 42-day postvaccination safety follow-up among ~200 ZOSTAVAX™ recipients