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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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00534248
First received: September 21, 2007
Last updated: November 4, 2014
Last verified: November 2014

September 21, 2007
November 4, 2014
October 2007
January 2010   (final data collection date for primary outcome measure)
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.
Vaccine efficacy
Complete list of historical versions of study NCT00534248 on ClinicalTrials.gov Archive Site
  • 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.

Increase in antibody response at 6 weeks post vaccination.
Not Provided
Not Provided
 
Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)
A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of Zostavax™ in Subjects 50-59 Years of Age

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Shingles
  • 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™
  • 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.
  • Experimental: Zostavax™
    Participants randomized to receive Zoster Vaccine, Live (Zostavax™).
    Intervention: Biological: Zoster Vaccine, Live (Zostavax™)
  • Placebo Comparator: Placebo
    Participants randomized to receive Placebo.
    Intervention: Biological: Comparator: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22439
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
50 Years to 59 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00534248
V211-022, 2007_551
Not Provided
Vice President of Late Stage Development, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2014

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