The purpose of the study was to assess the safety, tolerability, and immunogenicity of ZOSTAVAX™ in patients receiving chronic/maintenance corticosteroids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
309
A single dose of 0.65 ml Zoster Vaccine, Live, injected subcutaneously on Day 1
A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1.
Number of Participants With Serious Adverse Events (SAE)
A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.
Time frame: Up to 182 days postvaccination
Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination
The Geometric Mean Titer (GMT) of VZV antibodies in participants' serum samples was assessed by a glycoprotein enzyme-linked immunosorbent assay (gpELISA).
Time frame: 42 days postvaccination
Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination.
The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination.
Time frame: 42 days postvaccination
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