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Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01505647
Recruitment Status : Completed
First Posted : January 6, 2012
Results First Posted : July 3, 2013
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE January 4, 2012
First Posted Date  ICMJE January 6, 2012
Results First Submitted Date  ICMJE April 10, 2013
Results First Posted Date  ICMJE July 3, 2013
Last Update Posted Date April 12, 2017
Study Start Date  ICMJE April 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
  • Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody [ Time Frame: Day 1 and Week 6 postvaccination ]
    VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
  • Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers [ Time Frame: Day 1 (Baseline) to Week 6 postvaccination ]
    VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2012)
  • Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody [ Time Frame: Week 6 postvaccination ]
  • Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers [ Time Frame: Day 1 to Week 6 postvaccination ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
  • Number of Participants With One or More Adverse Experiences (AEs) [ Time Frame: Day 1 to Day 42 postvaccination ]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
  • Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination [ Time Frame: Day 1 to Day 42 postvaccination ]
    An SAE 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
  • Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination [ Time Frame: Day 1 to Day 182 postvaccination ]
    An SAE 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2012)
  • Number of participants with one or more adverse experiences [ Time Frame: Day 1 to Day 42 postvaccination ]
  • Number of participants with one or more serious adverse experiences [ Time Frame: Day 1 to Day 182 postvaccination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)
Official Title  ICMJE A Phase III Double-Blinded, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Made With an Alternative Manufacturing Process (AMP)
Brief Summary This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Herpes Zoster
  • Shingles
Intervention  ICMJE
  • Biological: Zoster Vaccine, Live (AMP)
    One approximately 0.65-mL injection subcutaneously on Day 1
  • Biological: Zoster Vaccine, Live
    One approximately 0.65-mL injection subcutaneously on Day 1
    Other Names:
    • ZOSTAVAX™
    • V211
Study Arms  ICMJE
  • Experimental: ZOSTAVAX™ (AMP)
    ZOSTAVAX™ manufactured with an alternative process
    Intervention: Biological: Zoster Vaccine, Live (AMP)
  • Active Comparator: ZOSTAVAX™
    ZOSTAVAX™ manufactured with the current process
    Intervention: Biological: Zoster Vaccine, Live
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2012)
498
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2012)
495
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • No fever on day of vaccination
  • History of varicella or residence in a VZV-endemic area for ≥30 years
  • Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control

Exclusion Criteria:

  • History of hypersensitivity reaction to any vaccine component
  • Prior receipt of any varicella or zoster vaccine
  • Prior history of herpes zoster
  • Have recently had another vaccination
  • Pregnant or breastfeeding
  • Use of immunosuppressive therapy
  • Known or suspected immune dysfunction
  • Concomitant antiviral therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01505647
Other Study ID Numbers  ICMJE V211-042
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2017

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