ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

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™.

Condition or disease Intervention/treatment Phase
Herpes Zoster Shingles Biological: Zoster Vaccine, Live (AMP) Biological: Zoster Vaccine, Live Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 498 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : April 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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)

  2. 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).


Secondary Outcome Measures :
  1. 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.


  2. 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

  3. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01505647     History of Changes
Other Study ID Numbers: V211-042
First Posted: January 6, 2012    Key Record Dates
Results First Posted: July 3, 2013
Last Update Posted: April 12, 2017
Last Verified: March 2017
Individual Participant Data (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


Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs