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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Herpes Zoster

Treatments: Biological: zoster vaccine live (ZOSTAVAX™); Biological: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00322231

2006_010

V211-014

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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101 participants in 2 patient groups

ZOSTAVAX™ / Placebo

Experimental group

Description:

Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2)

Treatment:

Biological: zoster vaccine live (ZOSTAVAX™)

Biological: Comparator: Placebo

Placebo / ZOSTAVAX™

Experimental group

Description:

Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2)

Treatment:

Biological: zoster vaccine live (ZOSTAVAX™)

Biological: Comparator: Placebo