A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)

Phase 3

Completed

• Conditions: Herpes Zoster
• Interventions: Biological: zoster vaccine live (ZOSTAVAX™)

• Registration Number: NCT00322231
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-02
• Study First Submitted QC: 2006-05-04
• Study First Posted: 2006-05-05
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Results First Submitted: 2010-05-12
• Results First Submitted QC: 2010-11-17
• Results First Posted: 2010-12-15
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-14
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment

Exclusion Criteria

• History of allergy to any vaccine component
• Prior receipt of a varicella or zoster vaccine
• Ability to defend against infection is suppressed by a medical condition or medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ZOSTAVAX™ / Placebo	zoster vaccine live (ZOSTAVAX™)	Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2)
Placebo / ZOSTAVAX™	zoster vaccine live (ZOSTAVAX™)	Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2)

Primary Outcome Measures

Name	Time	Method
Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination	To Day 28 postvaccination	SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination	4 weeks postvaccination	The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination	From prevaccination (baseline) to 4 weeks postvaccination	GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination