Status:
COMPLETED
Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older
Lead Sponsor:
GlaxoSmithKline
Conditions:
Herpes Zoster
Herpes Zoster Vaccine
Eligibility:
All Genders
70+ years
Phase:
PHASE3
Brief Summary
The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years. Two studies (Zoster...
Detailed Description
This protocol summary has been updated following Protocol Amendment 4 changes to study objectives and endpoints. Pooled analyses of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) will only be c...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- A male or female aged 70 years or older at the time of the first vaccination.
Exclusion
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- 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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy History of HZ.
- Previous vaccination against varicella or HZ.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation.
- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
- Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period.
- Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine.
- Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
- Acute disease and/or fever at the time of enrolment.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Key Trial Info
Start Date :
August 2 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2015
Estimated Enrollment :
14819 Patients enrolled
Trial Details
Trial ID
NCT01165229
Start Date
August 2 2010
End Date
July 24 2015
Last Update
April 27 2020
Active Locations (213)
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1
GSK Investigational Site
Mesa, Arizona, United States, 85213
2
GSK Investigational Site
Phoenix, Arizona, United States, 85018
3
GSK Investigational Site
Phoenix, Arizona, United States, 85020
4
GSK Investigational Site
Phoenix, Arizona, United States, 85050