Shingles Prevention Study (SPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00007501|
Recruitment Status : Completed
First Posted : January 1, 2001
Last Update Posted : July 4, 2013
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 or disease||Intervention/treatment||Phase|
|Herpes Zoster Postherpetic Neuralgia||Biological: Varicella-zoster vaccine Biological: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38456 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||CSP #403 - Trial of Varicella Zoster Vaccine for the Prevention of Herpes Zoster and Its Complications|
|Study Start Date :||November 1998|
|Actual Primary Completion Date :||April 2004|
|Actual Study Completion Date :||February 2011|
Experimental: Arm 1
Biological: Varicella-zoster vaccine
Immunization with 0.5 ml, live, attenuated (Oka/Merck) varicella-zoster vaccine.
Placebo Comparator: Arm 2
- Reduce burden of illness due to herpes zoster (HZ) [ Time Frame: Incidence of postherpetic neuralgia (PHN), where PHN is defined as HZ-associated pain greater than or equal to 3 persisting or appearing more than 30 days after the onset of the HZ rash ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007501
|Study Chair:||Michael N. Oxman||VA San Diego Healthcare System, San Diego|