ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED)

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

PHASE2

Total Enrollment

309 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-08-31

Brief Summary

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The purpose of the study was to assess the safety, tolerability, and immunogenicity of ZOSTAVAX™ in patients receiving chronic/maintenance corticosteroids.

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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

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ZOSTAVAX™

Participants administered ZOSTAVAX™ on Day 1.

Group Type EXPERIMENTAL

Zoster Vaccine, Live

Intervention Type BIOLOGICAL

A single dose of 0.65 ml Zoster Vaccine, Live, injected subcutaneously on Day 1

Placebo

Participants administered Placebo on Day 1.

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type BIOLOGICAL

A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1.

Interventions

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Zoster Vaccine, Live

A single dose of 0.65 ml Zoster Vaccine, Live, injected subcutaneously on Day 1

Intervention Type BIOLOGICAL

Comparator: Placebo

A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1.

Intervention Type BIOLOGICAL

Other Intervention Names

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V211

Eligibility Criteria

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Inclusion Criteria

* Varicella-history positive, herpes zoster (HZ)-history negative patients
* 60 years of age and older receiving chronic/maintenance systemic corticosteroid therapy at a daily dose of 5 to 20 mg of prednisone or equivalent for at least the 2 weeks immediately prior to enrollment and expected to continue to receive a daily dose of 5 to 20 mg of prednisone or equivalent for the 6-week primary safety follow-up period (dose may vary within this range during the 6-week postvaccination period)
* All females enrolling must be postmenopausal

Exclusion Criteria

* Patients with a history of hypersensitivity reaction to gelatin or neomycin
* Prior receipt of varicella or zoster vaccine; prior history of herpes zoster
* Immune globulin and/or blood products given within 5 months prior to or expected within the 6-week postvaccination period
* Receipt of any live virus vaccinations within 1 month or receipt of any inactivated vaccinations within 7 days prior to enrollment
* Known immune deficiency that is caused by a medical condition
* Any use in the 8 weeks prior to vaccination or for 6 weeks after vaccination other medications which may suppress the immune system including methotrexate, corticosteroids at a daily dose greater than 20 mg of prednisone or equivalent, agents used to treat cancer, or medications which alter the level of the immune response used to treat arthritis or other illnesses
* Concomitant use of antiviral therapy
* A history of alcohol abuse or recreational drug use

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No