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Sponsors and Collaborators: |
Department of Veterans Affairs Merck National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00007501 |
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.
Condition | Intervention | Phase |
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Herpes Zoster Postherpetic Neuralgia |
Biological: Varicella-zoster vaccine Biological: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | CSP#403 - Trial of Varicella Zoster Vaccine for the Prevention of Herpes Zoster and Its Complications |
Enrollment: | 38456 |
Study Start Date: | December 1997 |
Estimated Study Completion Date: | December 2010 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
varicella-zoster vaccine
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Biological: Varicella-zoster vaccine
Immunization with 0.5 ml, live, attenuated (Oka/Merck) varicella-zoster vaccine.
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2: Placebo Comparator
vaccine placebo
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Biological: Placebo
Placebo vaccine.
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Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Michael N. Oxman | VA San Diego Healthcare System, San Diego |
Responsible Party: | Department of Veterans Affairs ( Oxman, Michael - Study Chair ) |
Study ID Numbers: | 403 |
Study First Received: | December 29, 2000 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00007501 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
varicella-zoster vaccine,Herpes Zoster,Postherpeti |
Herpes Zoster Neuralgia, Postherpetic Neuralgia Chickenpox Pain Varicella Zoster Herpesviridae Infections |
Virus Diseases Signs and Symptoms Neuromuscular Diseases Peripheral Nervous System Diseases Neurologic Manifestations DNA Virus Infections Chicken pox |
Nervous System Diseases |