Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy
Condition: Herpes Zoster; Herpes Zoster Vaccine
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: GSK 1437173A; Placebo
Intervention description: 2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.; 2 doses administered by IM injection into the deltoid muscle of the non-dominant arm.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ≥18 years of age; Chemotherapy; Solid tumours; Immunogenicity; Herpes Zoster; Safety; Shingles

Summary:

      The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
      HZ/su vaccine in adults with solid tumours undergoing chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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
             subject:

               -  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.

        Exclusion Criteria:

          -  Subjects receiving only newer, more targeted therapies if not taken together with a
             classical chemotherapy.

          -  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
             injection unsafe.

          -  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).