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Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00534248
First received: September 21, 2007
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
  Purpose

This study will look at how well Zostavax™ works in preventing shingles in participants ages 50-59 years old.


Condition Intervention Phase
Shingles
 Biological: Zoster Vaccine, Live (Zostavax™)
Biological: Comparator: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of Zostavax™ in Subjects 50-59 Years of Age

Resource links provided by NLM:

MedlinePlus related topics: Shingles
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population.


Secondary Outcome Measures:
  • Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    VZV antibody response as measured by Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) in the group that received Zostavax™ compared with the group that received placebo, based on the random subcohort population.

  • Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period [ Time Frame: Through 42 days post-vaccination ] [ Designated as safety issue: Yes ]
    A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.


Enrollment: 22439
Study Start Date: October 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zostavax™
Participants randomized to receive Zoster Vaccine, Live (Zostavax™).
 Biological: Zoster Vaccine, Live (Zostavax™)
A single dose 0.65 ml Zostavax™ (Live, attenuated Zoster Vaccine) was administered by subcutaneous injection on Day 1.
Other Names:
  • V211
  • Zostavax™
Placebo Comparator: Placebo
Participants randomized to receive Placebo.
 Biological: Comparator: Placebo
A single dose of 0.65 ml Placebo (A vaccine stabilizer of Zostavax™ with no live virus) was administered by subcutaneous injection on Day 1.

  Eligibility

Ages Eligible for Study:   50 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be between 50 - 59 years of age
  • No fever on day of vaccination
  • Females of reproductive potential must be willing to use acceptable form of birth control

Exclusion Criteria:

  • Have received chicken pox or shingles vaccine
  • Have already had shingles
  • Have recently had another vaccination
  • Pregnant or breast feeding. Have participated in another research study in the last 30 days
  • You are taking certain antiviral drugs
  • History of allergic reaction to any vaccine component, including gelatin or neomycin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534248

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

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00534248     History of Changes
Other Study ID Numbers: V211-022, 2007_551
Study First Received: September 21, 2007
Results First Received: January 4, 2011
Last Updated: March 31, 2011
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 June 18, 2013