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: September 6, 2013
Last verified: September 2013
  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
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: September 6, 2013
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 April 16, 2014