We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00109122
Recruitment Status : Completed
First Posted : April 25, 2005
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients).

Condition or disease Intervention/treatment Phase
Shingles Biological: zoster vaccine live (Oka/Merck) Biological: Comparator: placebo (unspecified) Phase 2

Detailed Description:
The duration of treatment is 12 weeks.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Double-Blind, Placebo-Controled, Randomized Study to Evaluate Safety, Tolerability, and Immunogenicity After 1 and 2 Doses of Zoster Vaccine
Study Start Date : November 2001
Primary Completion Date : February 2003
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Biological: zoster vaccine live (Oka/Merck)
    Other Name: V211
    Biological: Comparator: placebo (unspecified)

Outcome Measures

Primary Outcome Measures :
  1. VZV ELISPOT response ~6 weeks after 1 and 2 doses [ Time Frame: 6 weeks after 1 and 2 doses ]

Secondary Outcome Measures :
  1. To assess the safety and tolerability of the zoster vaccine. To evaluate the long-term persistence of the VZV-specific cell mediate immunity and the VZV-specific antibody response at 1 through 3 years after 2 doses of vaccine or placebo [ Time Frame: 1 through 3 years after vaccination ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals who are at least 60 years of age with a history of varicella (shingles)
  • Females must have been postmenopausal.

Exclusion Criteria:

  • Subjects who did not previously participate in the main study of this protocol.
  • Subject had shingles since their 6 month follow-up visit in main phase of study.
Contacts and Locations

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): NCT00109122


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

Publications:
Study Data/Documents: CSR Synopsiis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00109122     History of Changes
Other Study ID Numbers: V211-007
2005_017
First Posted: April 25, 2005    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017

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