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A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00696709
First received: June 11, 2008
Last updated: October 6, 2014
Last verified: October 2014

June 11, 2008
October 6, 2014
December 2008
November 2009   (final data collection date for primary outcome measure)
  • Varicella zoster virus (VZV) vaccine will elicit an acceptable VZV-specific immune response as measured by gpELISA [ Time Frame: 28 days postdose 4 ] [ Designated as safety issue: No ]
  • To assess varicella zoster virus (VZV) vaccine safety and tolerability [ Time Frame: through 28 days postdose 4 ] [ Designated as safety issue: Yes ]
Varicella zoster virus (VZV) vaccine will elicit an acceptable VZV-specific immune response as measured by gpELISA. [ Time Frame: 28 days postdose 4 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00696709 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)
A Phase I, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy Adults

The purpose of the study is to see if an investigational vaccine for shingles is safe and well tolerated and brings about an acceptable antibody response.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Herpes Zoster
  • Shingles
  • Biological: Comparator: V212
    0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart
  • Biological: Comparator: Placebo
    Placebo; 4-dose regimen administered ~30 days apart.
  • Experimental: 1
    heat-treated VZV vaccine
    Intervention: Biological: Comparator: V212
  • Experimental: 2
    alternative inactivation method VZV vaccine A
    Intervention: Biological: Comparator: V212
  • Placebo Comparator: 3
    Placebo
    Intervention: Biological: Comparator: Placebo
  • Experimental: 4
    alternative inactivation method VZV vaccine B
    Intervention: Biological: Comparator: V212
  • Experimental: 5
    alternative inactivation method VZV vaccine C
    Intervention: Biological: Comparator: V212
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be 50 to 59 years of age
  • No fever on vaccination days
  • Must have had chickenpox or lived in an area where the chickenpox virus is prevalent for 30 or more years
  • Females of child-bearing potential must use acceptable forms of birth control

Exclusion Criteria:

  • Prior history of shingles
  • Prior receipt of any chickenpox or shingles vaccine
  • Pregnant or breastfeeding
  • Received or expect to receive a live virus vaccine (such as measles, mumps, rubella) from 4 weeks before the first visit through the last visit
  • Received or expect to receive an inactivated vaccine (such as tetanus or pneumonia) from 7 days before the first visit through the last visit
  • Received immunoglobulin or blood products
  • Receiving treatment that may weaken the immune system
  • Have an immune system disorder
Both
50 Years to 59 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00696709
V212-004, 2008_528
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2014

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