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Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00109122
First received: April 22, 2005
Last updated: January 27, 2010
Last verified: January 2010
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Shingles
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • VZV ELISPOT response ~6 weeks after 1 and 2 doses [ Time Frame: 6 weeks after 1 and 2 doses ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: November 2001
Study Completion Date: July 2006
Intervention Details:
    Biological: zoster vaccine live (Oka/Merck)
    Other Name: V211
    Biological: Comparator: placebo (unspecified)
Detailed Description:

The duration of treatment is 12 weeks.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109122

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00109122     History of Changes
Other Study ID Numbers: 2005_017, V211-007
Study First Received: April 22, 2005
Last Updated: January 27, 2010
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 May 21, 2013