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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014