Status:
COMPLETED
Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Herpes Zoster
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivid...
Detailed Description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female aged 60 years or older at the time of the first vaccination.
- Written informed consent obtained from the subject
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period, except inhaled and topical steroids are allowed.
- Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection.
- Previous vaccination against HZ.
- History of herpes zoster (Shingles).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject's medical history or physical examination as assessed by the investigator.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period.
- History of or current drug and/or alcohol abuse.
Key Trial Info
Start Date :
February 14 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2010
Estimated Enrollment :
715 Patients enrolled
Trial Details
Trial ID
NCT00434577
Start Date
February 14 2007
End Date
July 14 2010
Last Update
March 15 2019
Active Locations (11)
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1
GSK Investigational Site
Hradec Králové, Czechia, 500 01
2
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany, 68161
3
GSK Investigational Site
Würzburg, Bavaria, Germany, 97070
4
GSK Investigational Site
Hanover, Lower Saxony, Germany, 30625