Status:
COMPLETED
Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older
Lead Sponsor:
GlaxoSmithKline
Conditions:
Herpes Zoster
Eligibility:
All Genders
50+ 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 ≥ 50 years. Two studies \[ZOSTE...
Detailed Description
This protocol summary has been updated following Protocol Amendment 4 changes to study objectives and endpoints and the analyses of the objectives in 2 steps. Step 1 will include analyses of the foll...
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 50 years or older at the time of the first vaccination;
- Female subjects of non-childbearing potential may be enrolled in the study;
- For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative urine pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series;
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 enrollment;
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Pregnant or lactating female;
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Key Trial Info
Start Date :
August 2 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2015
Estimated Enrollment :
16165 Patients enrolled
Trial Details
Trial ID
NCT01165177
Start Date
August 2 2010
End Date
July 27 2015
Last Update
February 10 2021
Active Locations (274)
Enter a location and click search to find clinical trials sorted by distance.
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