ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED)
|ClinicalTrials.gov Identifier: NCT00546819|
Recruitment Status : Completed
First Posted : October 19, 2007
Results First Posted : August 15, 2011
Last Update Posted : April 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Herpes Zoster||Biological: Zoster Vaccine, Live Biological: Comparator: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||309 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase IIb Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live (Oka/Merck) in Patients on Chronic/Maintenance Corticosteroids|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
Participants administered ZOSTAVAX™ on Day 1.
Biological: Zoster Vaccine, Live
A single dose of 0.65 ml Zoster Vaccine, Live, injected subcutaneously on Day 1
Other Name: V211
Placebo Comparator: Placebo
Participants administered Placebo on Day 1.
Biological: Comparator: Placebo
A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1.
- Number of Participants With Serious Adverse Events (SAE) [ Time Frame: Up to 182 days postvaccination ]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.
- Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination [ Time Frame: 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).
- Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination. [ Time Frame: 42 days postvaccination ]The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546819
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|