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: July 15, 2014
Last verified: July 2014

August 11, 2005
July 15, 2014
August 2005
November 2005   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00130793 on ClinicalTrials.gov Archive Site
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
Not Provided
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
Not Provided
 
A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)
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)

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.

The duration of treatment is 4 weeks.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Herpes Zoster
  • 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
  • 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
  • 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
    Intervention: Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation
  • 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
    Intervention: Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation
Gilderman LI, Lawless JF, Nolen TM, Sterling T, Rutledge RZ, Fernsler DA, Azrolan N, Sutradhar SC, Wang WW, Chan IS, Schlienger K, Schödel F, Silber JL; Zostavax Protocol 010 Study Group. A double-blind, randomized, controlled, multicenter safety and immunogenicity study of a refrigerator-stable formulation of Zostavax. Clin Vaccine Immunol. 2008 Feb;15(2):314-9. Epub 2007 Dec 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
368
November 2005
November 2005   (final data collection date for primary outcome measure)

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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00130793
V211-010, 2005_035
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP