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

• 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: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Tracking Information

• First Submitted Date: January 4, 2012
• First Posted Date: January 6, 2012
• Results First Submitted Date: April 10, 2013
• Results First Posted Date: July 3, 2013
• Last Update Posted Date: April 12, 2017
• Study Start Date: April 2012
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention

Condition

• Herpes Zoster
• Shingles

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 19, 2012): 498
• Original Estimated Enrollment (submitted: January 4, 2012): 495
• Actual Study Completion Date: November 2012
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT01505647
• Other Study ID Numbers: V211-042
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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: Merck Sharp & Dohme Corp.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Merck Sharp & Dohme Corp.
• Verification Date: March 2017