ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546819
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|