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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
ClinicalTrials.gov Identifier:
NCT01505647
First received: January 4, 2012
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  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:

MedlinePlus related topics: Shingles
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Geometric mean titer (GMT) of varicella zoster virus (VZV) antibody [ Time Frame: Week 6 postvaccination ] [ Designated as safety issue: No ]
  • Geometric mean fold rise (GMFR) in VZV antibody titers [ Time Frame: Day 1 to Week 6 postvaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with one or more adverse experiences [ Time Frame: Day 1 to Day 42 postvaccination ] [ Designated as safety issue: Yes ]
  • Number of participants with one or more serious adverse experiences [ Time Frame: Day 1 to Day 182 postvaccination ] [ Designated as safety issue: Yes ]

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: AMP Vaccine Biological: Zoster Vaccine Live (AMP)
One approximately 0.65-mL injection subcutaneously on Day 1
Active Comparator: Current Process Vaccine 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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01505647     History of Changes
Other Study ID Numbers: V211-042
Study First Received: January 4, 2012
Last Updated: December 14, 2012
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 May 19, 2013