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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01505647
First received: January 4, 2012
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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™.


Condition Intervention Phase
Herpes Zoster
Shingles
Biological: Zoster Vaccine, Live (AMP)
Biological: Zoster Vaccine, Live
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 Double-Blinded, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Made With an Alternative Manufacturing Process (AMP)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody [ Time Frame: Day 1 and Week 6 postvaccination ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Number of Participants With One or More Adverse Experiences (AEs) [ Time Frame: Day 1 to Day 42 postvaccination ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 498
Study Start Date: April 2012
Study Completion Date: November 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZOSTAVAX™ (AMP)
ZOSTAVAX™ manufactured with an alternative process
Biological: Zoster Vaccine, Live (AMP)
One approximately 0.65-mL injection subcutaneously on Day 1
Active Comparator: ZOSTAVAX™
ZOSTAVAX™ manufactured with the current process
Biological: Zoster Vaccine, Live
One approximately 0.65-mL injection subcutaneously on Day 1
Other Names:
  • ZOSTAVAX™
  • V211

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01505647     History of Changes
Other Study ID Numbers: V211-042
Study First Received: January 4, 2012
Results First Received: April 10, 2013
Last Updated: July 1, 2014
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 July 28, 2014