Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A

The Protocol Posting has been updated following Protocol amendment 2, Sep 2009. The sections
impacted are: eligibility criteria.

Inclusion Criteria:

- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol;

- Male and female subjects at least 18 years old at the time of vaccination;

- Serological evidence of prior VZV infection for all subjects born in 1980 or later and
for subjects born outside the US before 1980 in a tropical or sub-tropical region. No
testing for serological evidence of prior VZV infection is required for US subjects
born before 1980;

- Has undergone autologous HCT within the past 50-70 days for treatment of Hodgkin
lymphoma, non-Hodgkin lymphoma (T or B cell), myeloma or acute myeloid leukemia, and
there are no plans for additional HCTs

- Written informed consent obtained from the subject;

- If the subject is female, she must be of non-childbearing potential or if she is of
childbearing potential, she must practice adequate contraception for 30 days prior to
vaccination, have a negative pregnancy test and continue such precautions for 2 months
after completion of the vaccination series.

Exclusion Criteria:

- Use of any investigational non-registered product other than the study vaccine(s)
within 30 days preceding the first dose of study vaccine, or planned use during the
study period;

- Administration or planned administration of a vaccine that is not part of the study
protocol since transplantation. However licensed non-replicating vaccines (i.e.
inactivated and subunit vaccines, including inactivated and subunit influenza
vaccines, with or without adjuvant) may be administered up to 8 days prior to dose 1;

- Administration of immunoglobulins since transplantation;

- Previous vaccination against varicella or HZ;

- History of HZ within the previous 12 months;

- Known exposure to VZV since transplantation;

- Evidence of active infection at the time of enrollment including a temperature of ≥
37.5° C or any serious HCT-related complication;

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine;

- Hypersensitivity or intolerance to acyclovir or valacyclovir;

- Pregnant or lactating female.