NCT00231816

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
763

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

December 15, 2010

Completed
Last Updated

September 21, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

September 30, 2005

Results QC Date

May 12, 2010

Last Update Submit

September 2, 2015

Conditions

Herpes Zoster

Keywords

Prevention of Herpes Zoster

Outcome Measures

Primary Outcomes (1)

  • Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses

    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.

    4 weeks

Other Outcomes (4)

  • Geometric Mean Fold Rise (GMFR) in VZV gpELISA Antibody Titers From Prevaccination to 4 Weeks Postvaccination

    prevaccination to 4 weeks postvaccination

  • Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination

    4 weeks postvaccination

  • GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination

    4 weeks postvaccination

  • +1 more other outcomes

Study Arms (2)

Concomitant

EXPERIMENTAL

Zostavax concomitantly with influenza vaccine on Day 1, placebo at week 4

Biological: ZOSTAVAX™ (concomitant)Biological: Comparator: Influenza Vaccine

Nonconcomitant

EXPERIMENTAL

Influenza vaccine and Zostavax placebo on Day 1, Zostavax at week 4

Biological: Comparator: Influenza VaccineBiological: ZOSTAVAX™ (Nonconcomitant)

Interventions

ZOSTAVAX™ (concomitant)BIOLOGICAL

a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4

Also known as: V211
Concomitant
Comparator: Influenza VaccineBIOLOGICAL

a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1

Also known as: Fluzone, Vaxigrip
ConcomitantNonconcomitant
ZOSTAVAX™ (Nonconcomitant)BIOLOGICAL

Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4

Nonconcomitant

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 50 years of age or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kerzner B, Murray AV, Cheng E, Ifle R, Harvey PR, Tomlinson M, Barben JL, Rarrick K, Stek JE, Chung MO, Schodel FP, Wang WW, Xu J, Chan IS, Silber JL, Schlienger K. Safety and immunogenicity profile of the concomitant administration of ZOSTAVAX and inactivated influenza vaccine in adults aged 50 and older. J Am Geriatr Soc. 2007 Oct;55(10):1499-507. doi: 10.1111/j.1532-5415.2007.01397.x.

    PMID: 17908055BACKGROUND

  • Sutradhar SC, Wang WW, Schlienger K, Stek JE, Xu J, Chan IS, Silber JL. Comparison of the levels of immunogenicity and safety of Zostavax in adults 50 to 59 years old and in adults 60 years old or older. Clin Vaccine Immunol. 2009 May;16(5):646-52. doi: 10.1128/CVI.00407-08. Epub 2009 Mar 4.

    PMID: 19261769BACKGROUND

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster VaccineInfluenza Vaccinesvaxigrip

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Chickenpox VaccineHerpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

September 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

September 21, 2015

Results First Posted

December 15, 2010

Record last verified: 2015-09