NCT00109122

Brief Summary

The purpose of this study is to determine the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_2

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

November 1, 2001

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

April 22, 2005

Last Update Submit

March 14, 2017

Conditions

Shingles

Outcome Measures

Primary Outcomes (1)

  • VZV ELISPOT response ~6 weeks after 1 and 2 doses

    6 weeks after 1 and 2 doses

Secondary Outcomes (1)

  • To assess the safety and tolerability of the zoster vaccine. To evaluate the long-term persistence of the VZV-specific cell mediate immunity and the VZV-specific antibody response at 1 through 3 years after 2 doses of vaccine or placebo

    1 through 3 years after vaccination

Interventions

zoster vaccine live (Oka/Merck)BIOLOGICAL
Also known as: V211
Comparator: placebo (unspecified)BIOLOGICAL

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who are at least 60 years of age with a history of varicella (shingles)
  • Females must have been postmenopausal.

You may not qualify if:

  • Subjects who did not previously participate in the main study of this protocol.
  • Subject had shingles since their 6 month follow-up visit in main phase of study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Vermeulen JN, Lange JM, Tyring SK, Peters PH, Nunez M, Poland G, Levin MJ, Freeman C, Chalikonda I, Li J, Smith JG, Caulfield MJ, Stek JE, Chan IS, Vessey R, Schodel FP, Annunziato PW, Schlienger K, Silber JL. Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults >/=60 years of age. Vaccine. 2012 Jan 20;30(5):904-10. doi: 10.1016/j.vaccine.2011.11.096. Epub 2011 Dec 7.

    PMID: 22154769RESULT

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Chickenpox VaccineHerpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2005

First Posted

April 25, 2005

Study Start

November 1, 2001

Primary Completion

February 1, 2003

Study Completion

July 1, 2006

Last Updated

March 15, 2017

Record last verified: 2017-03