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

January 14, 2015 updated by: Merck Sharp & Dohme LLC

A Phase III Clinical Trial to Study the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live in Subjects With a History of Herpes Zoster

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ZOSTAVAX™ / Placebo
Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2)
Biological: zoster vaccine live (ZOSTAVAX™)
1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live
Other Names:
  • Zostavax
Biological: Comparator: Placebo
1 dose 0.65 mL/dose subcutaneous injection of placebo.
Experimental: Placebo / ZOSTAVAX™
Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2)
Biological: zoster vaccine live (ZOSTAVAX™)
1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live
Other Names:
  • Zostavax
Biological: Comparator: Placebo
1 dose 0.65 mL/dose subcutaneous injection of placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
Time Frame: 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
To Day 28 postvaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
Time Frame: 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
4 weeks postvaccination
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
Time Frame: From prevaccination (baseline) to 4 weeks postvaccination
GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination
From prevaccination (baseline) to 4 weeks postvaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

May 2, 2006

First Submitted That Met QC Criteria

May 4, 2006

First Posted (Estimate)

May 5, 2006

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 14, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V211-014
  • 2006_010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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