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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:
ClinicalTrials.gov Identifier:
NCT00231816
First Posted: October 4, 2005
Last Update Posted: September 21, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]

    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00231816


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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00231816     History of Changes
Other Study ID Numbers: V211-011
2005_036
First Submitted: September 30, 2005
First Posted: October 4, 2005
Results First Submitted: May 12, 2010
Results First Posted: December 15, 2010
Last Update Posted: September 21, 2015
Last Verified: September 2015

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

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