A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00130793
First received: August 11, 2005
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.


Condition Intervention Phase
Herpes Zoster
Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation
Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of a Refrigerator-Stable Formulation of Zoster Vaccine Live (Oka/Merck)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS.


Secondary Outcome Measures:
  • Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Vaccine-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) serious adverse experiences are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose


Other Outcome Measures:
  • Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination [ Time Frame: From prevaccination (baseline) to 4 weeks postvaccination ] [ Designated as safety issue: No ]
    GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination


Enrollment: 368
Study Start Date: August 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: zoster vaccine live (Oka/Merck) refrigerated formulation
ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation
1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1
Active Comparator: zoster vaccine live (Oka/Merck) frozen formulation
ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation
1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1

Detailed Description:

The duration of treatment is 4 weeks.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals who are at least 50 years of age or older with a history of varicella (chicken pox)

Exclusion Criteria:

  • Prior history of herpes zoster (shingles)
  • Prior receipt of varicella or zoster vaccine
  • Immunosuppressed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130793

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00130793     History of Changes
Other Study ID Numbers: V211-010, 2005_035
Study First Received: August 11, 2005
Results First Received: May 11, 2009
Last Updated: January 16, 2014
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 April 21, 2014