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A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)

NCT ID: NCT00322231

Last Updated: 2015-01-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-07-31

Brief Summary

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The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.

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Detailed Description

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Conditions

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Herpes Zoster

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ZOSTAVAX™ / Placebo

Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2)

Group Type EXPERIMENTAL

zoster vaccine live (ZOSTAVAX™)

Intervention Type BIOLOGICAL

1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live

Comparator: Placebo

Intervention Type BIOLOGICAL

1 dose 0.65 mL/dose subcutaneous injection of placebo.

Placebo / ZOSTAVAX™

Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2)

Group Type EXPERIMENTAL

zoster vaccine live (ZOSTAVAX™)

Intervention Type BIOLOGICAL

1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live

Comparator: Placebo

Intervention Type BIOLOGICAL

1 dose 0.65 mL/dose subcutaneous injection of placebo.

Interventions

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zoster vaccine live (ZOSTAVAX™)

1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live

Intervention Type BIOLOGICAL

Comparator: Placebo

1 dose 0.65 mL/dose subcutaneous injection of placebo.

Intervention Type BIOLOGICAL

Other Intervention Names

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Zostavax

Eligibility Criteria

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Inclusion Criteria

* Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment

Exclusion Criteria

* History of allergy to any vaccine component
* Prior receipt of a varicella or zoster vaccine
* Ability to defend against infection is suppressed by a medical condition or medication
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Mills R, Tyring SK, Levin MJ, Parrino J, Li X, Coll KE, Stek JE, Schlienger K, Chan IS, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. Vaccine. 2010 Jun 7;28(25):4204-9. doi: 10.1016/j.vaccine.2010.04.003. Epub 2010 Apr 21.

Reference Type RESULT
PMID: 20416263 (View on PubMed)

Other Identifiers

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2006_010

Identifier Type: -

Identifier Source: secondary_id

V211-014

Identifier Type: -

Identifier Source: org_study_id

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