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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003651-20-FR

Enrollment

300

Registered

2007-01-19

Start date

2008-03-18

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: ZOSTAVAX™ Product Name: Zoster Vaccine Live Product Code: V211 Pharmaceutical Form: Powder for injection* INN or Proposed IN

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. ; 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. ;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.	—

Measure

Time frame

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. ; 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. ;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.

—

Countries

Belgium, France, Germany, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026