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Shingles Prevention Study

NCT00007501 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38456

Last updated 2013-07-04

No results posted yet for this study

Summary

The incidence and severity of HZ (or shingles), as well as the frequency and severity of its complications, increases markedly with increasing age. More than half of all cases occur in persons over the age of 60. Even without complications, HZ can interfere with an elderly patient's ability to perform essential activities of daily living, resulting in a loss of independence that is emotionally devastating and frequently irreversible. The most common complication of HZ in elderly persons is postherpetic neuralgia (PHN), which frequently results in disordered sleep, chronic fatigue, anxiety and severe depression. Antiviral therapy has a modest impact on the acute phase of HZ. However, it does not appear to prevent the development of PHN.

This study is a 5.5 year randomized, double-blind, placebo-controlled, efficacy trial to determine whether vaccination with live-attenuated Oka/Merck varicella-zoster decreases the incidence and/or severity of herpes zoster (HZ) and its complications in adults 60 years of age and older.

Conditions

  • Herpes Zoster
  • Postherpetic Neuralgia

Interventions

BIOLOGICAL

Varicella-zoster vaccine

Immunization with 0.5 ml, live, attenuated (Oka/Merck) varicella-zoster vaccine.

BIOLOGICAL

Placebo

Placebo vaccine

Sponsors & Collaborators

Principal Investigators

  • Michael N. Oxman · VA San Diego Healthcare System, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1998-11-30
Primary Completion
2004-04-30
Completion
2011-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00007501 on ClinicalTrials.gov