Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

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 following objectives of ZOSTER-006 (NCT01165177): all HZ
VE objectives and all reactogenicity/safety and immunogenicity objectives. At step 2, all
objectives of study ZOSTER-006 (NCT01165177) will be analyzed. Objectives already analyzed at
step 1 will be re-analyzed (confirmatory descriptive in case of inferential analysis at step
1 or descriptive analysis otherwise). At step 2, pooled analyses of studies ZOSTER-006
(NCT01165177) and ZOSTER-022 (NCT01165229) are planned; overall PHN VE in subjects ≥ 70 YOA,
and other pre-specified endpoints will be analyzed.

Inclusion Criteria:

- 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 Criteria:

- 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.