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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00322231
First received: May 2, 2006
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Herpes Zoster
Biological: zoster vaccine live (ZOSTAVAX™)
Biological: Comparator: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase III Clinical Trial to Study the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live in Subjects With a History of Herpes Zoster

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination [ Time Frame: To Day 28 postvaccination ] [ Designated as safety issue: Yes ]
    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:
  • Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination [ Time Frame: 4 weeks postvaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: From prevaccination (baseline) to 4 weeks postvaccination ] [ Designated as safety issue: No ]
    GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination


Enrollment: 101
Study Start Date: May 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Zostavax
Biological: Comparator: Placebo
1 dose 0.65 mL/dose subcutaneous injection of placebo.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322231

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00322231     History of Changes
Other Study ID Numbers: V211-014, 2006_010
Study First Received: May 2, 2006
Results First Received: May 12, 2010
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 15, 2014