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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: April 22, 2005
Last updated: March 10, 2015
Last verified: March 2015
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
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:

Further study details as provided by Merck Sharp & Dohme Corp.:

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
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: zoster vaccine live (Oka/Merck)
    Other Name: V211
    Biological: Comparator: placebo (unspecified)
Detailed Description:
The duration of treatment is 12 weeks.

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00109122

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00109122     History of Changes
Other Study ID Numbers: V211-007  2005_017 
Study First Received: April 22, 2005
Last Updated: March 10, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Herpes Zoster
DNA Virus Infections
Herpesviridae Infections
Virus Diseases processed this record on May 26, 2016