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OpenTrials
Completed

NCT Number: NCT00322231

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

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.

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zoster vaccine live (ZOSTAVAX™)

Biological

1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live

Other names: Zostavax

Comparator: Placebo

Biological

1 dose 0.65 mL/dose subcutaneous injection of placebo.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 5, 2006
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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