An Observer-blind Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults ≥18 Years of Age With Solid Tumours Receiving Chemotherapy
- Subjects who, in the opinion of the investigator, can and will comply with the
requirements of the protocol.
- Written informed consent obtained from the subject.
- A male or female aged 18 years or older (and has reached the age of legal consent) at
the time of study entry (i.e., when informed consent is signed).
- Subject who has been diagnosed with one or more solid tumours (defined as a solid
malignancy, i.e., not a blood element malignancy).
- Subject who is receiving or will receive a cytotoxic or immunosuppressive
chemotherapy (such that the study vaccine can be administered at the latest at the
start of the second cycle of chemotherapy).
- Life expectancy of greater than one year.
- Female subjects of non-childbearing potential may be enrolled in the study:
- Non-childbearing potential is defined as pre-menarche, current tubal ligation,
hysterectomy, ovariectomy or post-menopause;
- Female subjects of childbearing potential may be enrolled in the study, if the
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative 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.
- Subjects receiving only newer, more targeted therapies if not taken together with a
- Chronic administration and/or planned administration of systemic glucocorticoids
within one month prior to the first vaccine dose and up to Visit 3 (Month 2).
Inhaled, intra-articularly injected, and topical steroids are allowed.
- Previous vaccination against HZ or varicella within 12 months preceding the first
dose of study vaccine/ placebo.
- Planned administration during the study of a HZ vaccine (including an investigational
or non-registered vaccine) other than the study vaccine.
- Previous chemotherapy course less than one month before first study vaccination.
- Occurrence of a varicella or HZ episode by clinical history within the 12 months
preceding the first dose of study vaccine/ placebo.
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine or study material and equipment.
- Administration or planned administration of a live vaccine in the period starting 30
days before the first dose of study vaccine and ending 30 days after the last dose of
study vaccine, or, administration or planned administration of a non-replicating
vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
- HIV infection by clinical history.
- Acute disease and/or fever at the time of vaccination. Acute disease is defined as
the presence of a moderate or severe illness with or without fever, but excludes the
underlying malignancy, as well as the expected symptoms/signs associated with that
disease or its treatment:
- Fever is defined as temperature ≥ 37.5°C /99.5°F on oral, axillary or tympanic
setting, or ≥ 38.0°C /100.4°F on rectal setting. The preferred route for
recording temperature in this study will be oral.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
infection) without fever, may receive the first dose of study vaccine/ placebo
at the discretion of the investigator.
- Any condition which, in the judgment of the investigator would make intramuscular
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive
precautions (if of childbearing potential) before Month 3 (i.e., 2 months after the
last dose of study vaccine/ placebo).