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

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ClinicalTrials.gov Identifier: NCT00322231
Recruitment Status : Completed
First Posted : May 5, 2006
Results First Posted : December 15, 2010
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : May 2006
Primary Completion Date : July 2007
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

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 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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322231


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00322231     History of Changes
Other Study ID Numbers: V211-014
2006_010
First Posted: May 5, 2006    Key Record Dates
Results First Posted: December 15, 2010
Last Update Posted: January 26, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs