Study Results
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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COMPLETED
41 participants
OBSERVATIONAL
2007-08-31
2007-12-31
Brief Summary
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Detailed Description
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The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Group A
Collection of lesion samples and blood sampling from subjects aged \>=50 years with clinically diagnosed herpes zoster
Herpes zoster sampling procedure for VZV PCR
Four types of HZ lesions will be collected (Swabs of vesicles, Swabs of papules, Swabs of crusts and Crusts), 3 replicates of each.
Blood sampling
Two blood samples taken, the first at the time of HZ diagnosis and the second one month later.
Interventions
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Herpes zoster sampling procedure for VZV PCR
Four types of HZ lesions will be collected (Swabs of vesicles, Swabs of papules, Swabs of crusts and Crusts), 3 replicates of each.
Blood sampling
Two blood samples taken, the first at the time of HZ diagnosis and the second one month later.
Eligibility Criteria
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Inclusion Criteria
* A male or female aged 50 years or older at the time of the subject's enrolment.
* Written informed consent obtained from the subject.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion Criteria
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccination, including corticosteroids, except inhaled and topical steroids are allowed.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
* Previous vaccination against herpes zoster.
* Confirmed or suspected immunosuppression, based on medical history or physical examination (no laboratory testing required).
* A family history of congenital or hereditary immunodeficiency.
* History of or chronic alcohol or drug abuse.
50 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Hamburg, City state of Hamburg, Germany
GSK Investigational Site
Husum, Schleswig-Holstein, Germany
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany
Countries
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Other Identifiers
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109999
Identifier Type: -
Identifier Source: org_study_id
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