Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II, Single-blind, Randomized, Controlled, Multicentre Vaccination Study to Evaluate the Safety and Immune Response of the GSK Biologicals Zoster Vaccine, gE/AS01B, and to Compare 3 Doses of gE With AS01B Adjuvant in Healthy Elderly Subjects, Aged 60 to 69 Years and 70 Years and Above.
Brief Summary: Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 \& 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity \& safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period.

No new subjects will be enrolled during the extension phases of the study.


Options:
A: Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* A male or female aged 50 years or older at the time of the first vaccination with the study vaccine(s).
* Written informed consent obtained from the subject.
* 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:

* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. A prednisone dose of \< 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
* Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine(s) and ending 30 days after the last dose of study vaccine. This includes any type of vaccine such as live, inactivated and subunit vaccines.
* Administration of long-acting immune-modifying drugs within six months prior to the first vaccine dose or expected administration at any time 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 vaccine/product.
* Previous vaccination against Varicella-zoster virus (VZV) or HZ and/or planned administration during the study of an HZ or VZV vaccine other than the study vaccine.
* History of HZ.
* History of documented pneumococcal infection within 5 previous years.
* Prior receipt of any pneumococcal vaccine or planned use of this vaccine during the study period, other than the study vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy .
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Acute disease and/or fever at the time of enrolment.

  * Fever is defined as temperature ≥ 37.5°C /99.5°F by oral route. The preferred route for recording temperature in this study will be oral.
  * Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after the last dose of study vaccine.
* Any persons with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal failure, nephrotic syndrome, and functional or anatomic asplenia.
* Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
* Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.
B: Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A male or female aged 60 years or older at the time of the first vaccination.
* Written informed consent obtained from the subject

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period, except inhaled and topical steroids are allowed.
* Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection.
* Previous vaccination against HZ.
* History of herpes zoster (Shingles).
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject's medical history or physical examination as assessed by the investigator.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period.
* History of or current drug and/or alcohol abuse.
C: Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* A male or female ≥ 65 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject prior to performing any study specific procedure.

For the No prev-Zvax group only:

• No previous vaccination with Zostavax.

For the Prev-Zvax group only:

• Previous vaccination with Zostavax ≥ 5 calendar years earlier.

* Documentation indicating the date of previous Zostavax vaccination will be required.

Exclusion Criteria:

* Previous vaccination with Zostavax \< 5 calendar years earlier and/or anyone that ever received more than a single dose of Zostavax.
* Previous vaccination against VZV, administration of HZ/su vaccine or any other investigational or non-registered HZ vaccine (except Zostavax for the Prev-Zvax group).
* Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as \> 14 consecutive days) of immunosuppressants or other immune-modifying drugs in the period starting 6 months prior to the first dose of vaccine. (For corticosteroids, a prednisone dose of \< 20 mg/day, or equivalent, is allowed.) Inhaled, topical and intra-articular corticosteroids are allowed.
* Administration of long-acting immune-modifying drugs (e.g., infliximab) in the period starting 6 months prior to the first vaccine dose or expected administration at any time during the study period.
* 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 in the period starting 8 days prior to and ending 14 days after either dose of study vaccine.
* Current participation in or planned concurrent participation 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.
* Planned administration of an HZ vaccine (including an investigational or non-registered vaccine) other than the study vaccine during the entire study.
* History of HZ or any suspected HZ between the screening visit and Visit 1.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product.
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus \[HIV\] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
* Acute disease and/or fever at the time of enrolment.

  * Fever is defined as temperature ≥ 37.5°C (99.5°F) by oral route, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The recommended route for recording temperature in this study will be oral.
  * Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
* Administration of immunoglobulins and/or any blood products in the period starting 3 months preceding the first dose of study vaccine or planned administration during the study period.
* Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study.
* Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
* Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.
D: 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 70 years or older at the time of the first vaccination.

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 enrolment.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

Answer: B