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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Collaborators: |
Merck National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by (Responsible Party): | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00007501 |
Purpose
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 |
|---|---|---|
|
Herpes Zoster Postherpetic Neuralgia |
Biological: Varicella-zoster vaccine Biological: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
varicella-zoster vaccine
|
Biological: Varicella-zoster vaccine
Immunization with 0.5 ml, live, attenuated (Oka/Merck) varicella-zoster vaccine.
|
|
Placebo Comparator: 2
vaccine placebo
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Biological: Placebo
Placebo vaccine
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 22 Study Locations| Study Chair: | Michael N. Oxman | VA San Diego Healthcare System, San Diego |
More Information
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00007501 History of Changes |
| Obsolete Identifiers: | NCT00023257, NCT00001907, NCT00006065, NCT00006069 |
| Other Study ID Numbers: | 403 |
| Study First Received: | December 29, 2000 |
| Last Updated: | August 26, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
varicella-zoster vaccine |
|
Herpes Zoster Neuralgia Neuralgia, Postherpetic Herpesviridae Infections DNA Virus Infections Virus Diseases |
Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms |