Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2006-07-31

Brief Summary

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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).

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Detailed Description

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The duration of treatment is 12 weeks.

Conditions

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Shingles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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zoster vaccine live (Oka/Merck)

Intervention Type BIOLOGICAL

Comparator: placebo (unspecified)

Intervention Type BIOLOGICAL

Other Intervention Names

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V211

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes