A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00231816
First received: September 30, 2005
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to determine whether the investigational zoster vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile when given concomitantly with another vaccine.


Condition Intervention Phase
Herpes Zoster
Biological: ZOSTAVAX™ (concomitant)
Biological: Comparator: Influenza Vaccine
Biological: ZOSTAVAX™ (Nonconcomitant)
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 Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of V211 Administered Concomitantly Versus Nonconcomitantly With Influenza Virus Vaccine (Inactivated)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The Geometric mean titer (GMT) of the VZV glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody responses at Week 4 postvaccination in participants who received ZOSTAVAX™ concomitantly with influenza vaccine was compared to that in subjects who received influenza vaccine and ZOSTAVAX™ nonconcomitantly.


Other Outcome Measures:
  • Geometric Mean Fold Rise (GMFR) in VZV gpELISA Antibody Titers From Prevaccination to 4 Weeks Postvaccination [ Time Frame: prevaccination to 4 weeks postvaccination ] [ Designated as safety issue: No ]

    GMFR of the VZV gpELISA antibody titers from prevaccination

    to 4 weeks postvaccination when ZOSTAVAX™ is administered concomitantly with influenza vaccine


  • Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination [ Time Frame: 4 weeks postvaccination ] [ Designated as safety issue: No ]
    GMT of the H1N1 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly

  • GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination [ Time Frame: 4 weeks postvaccination ] [ Designated as safety issue: No ]
    GMT of the H3N2 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly

  • GMTs of B Strain Antibody Responses at 4 Weeks Postvaccination [ Time Frame: 4 weeks postvaccination ] [ Designated as safety issue: No ]
    GMT of the B strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly


Enrollment: 763
Study Start Date: September 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concomitant
Zostavax concomitantly with influenza vaccine on Day 1, placebo at week 4
Biological: ZOSTAVAX™ (concomitant)
a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4
Other Name: V211
Biological: Comparator: Influenza Vaccine
a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1
Other Name: Fluzone, Vaxigrip
Experimental: Nonconcomitant
Influenza vaccine and Zostavax placebo on Day 1, Zostavax at week 4
Biological: Comparator: Influenza Vaccine
a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1
Other Name: Fluzone, Vaxigrip
Biological: ZOSTAVAX™ (Nonconcomitant)
Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults 50 years of age or older

Exclusion Criteria:

  • Prior history of Herpes Zoster (shingles)
  • Prior receipt of varicella or zoster vaccine
  • Immunosuppressed
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231816

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00231816     History of Changes
Other Study ID Numbers: V211-011, 2005_036
Study First Received: September 30, 2005
Results First Received: May 12, 2010
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Prevention of Herpes Zoster

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 25, 2014