Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)
Brief Summary: This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.


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 (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent). 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 (but not limited to) live, inactivated and subunit vaccines (e.g., inactivated and subunit influenza vaccines).
* Administration of long-acting immune-modifying drugs (e.g. infliximab) 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 (pharmaceutical product or device).
* Previous vaccination against VZV or HZ and/or planned administration during the study of an HZ or VZV vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
* History of HZ.
* Vaccination against diphtheria, or tetanus in the last five years or planned vaccination against diphtheria or tetanus during the study period, other than the study vaccine(s).
* Administration of a combined tetanus, diphtheria and pertussis (Tdap) vaccine at any time prior to study entry.
* 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).
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines including prior severe allergic reaction following tetanus-toxoid, diphtheria-toxoid or pertussis-containing vaccine.
* Hypersensitivity to latex. Note: The investigational HZ/su vaccine does not contain latex.
* 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 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.
* Encephalopathy (e.g. coma, decreased consciousness, prolonged seizures) not attributable to an identifiable cause within 7 days of administration of a previous pertussis antigen-containing vaccine.
* Progressive or unstable neurologic disorder.
* History of Arthus-type hypersensitivity reaction following a prior dose of a tetanus-toxoid containing vaccine within the last 10 years.
* History of Guillain-Barré syndrome within 6 weeks of receipt of a prior vaccine containing tetanus toxoid.
B: Inclusion Criteria:

* Adults 60 years of age and older.
* History of Chickenpox.
* Have given written informed consent prior to enrollment.
* History of varicella or long-term (greater than or equal to 30 years) residence in the continental USA.

Exclusion Criteria:

* No history of shingles, no current history of immune suppression (e.g. malignancy or neoplastic disease, corticosteroid therapy).
* No immunosuppression resulting from disease (e.g., malignancy; HIV infection), corticosteroids (except intermittent topical or inhaled corticosteroid \[greater than 800 mcg/day beclomethasone dipropionate or equivalent\]), or other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation).
* No active neoplastic disease (except local skin cancer or other malignancies \[e.g., prostate cancer\] that are stable in the absence of immunosuppressive/cytotoxic therapy).
* No prior Herpes Zoster.
* No prior receipt of varicella vaccine.
* No allergic sensitivity to neomycin.
* No history of anaphylactoid reaction to gelatin.
* No significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 5 years).
* Not ambulatory (must not be bed-ridden or homebound).
* No receipt of immune globulin or any other blood product within 3 months before or planned during the 3-5 year study period.
* No receipt of any other immunizations within one month before study vaccination (2 weeks in the case of inactivated influenza vaccines or other non-replicating immunization products \[e.g., dT, pneumococcal vaccine, hepatitis A vaccine, hepatitis B vaccine\]), or scheduled within 6 weeks after study vaccination.
* Not currently receiving antiviral therapy.
* No other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss) that, in the opinion of the investigator, might interfere with the evaluations required by the study.
* No intercurrent illness (e.g., urinary tract infection, influenza) that might interfere with the interpretation of the study.
* No females who are pre-menopausal.
* No subjects unlikely to adhere to protocol follow-up.
* No subjects involved in a conflicting (vaccine or investigational drug) clinical trial.
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:

* Prior history of varicella (chickenpox) or residence in a country with endemic varicella zoster virus infection for at least 30 years
* Temperature less than 100.4 °F on day of vaccination
* Female participants of reproductive potential must have a negative pregnancy test and agree to remain abstinent or use two acceptable contraceptive methods for 3 months postvaccination
* In good health

Exclusion Criteria:

* History of hypersensitivity reaction to any vaccine component, including gelatin or neomycin
* Household exposure to pregnant women who have not had chickenpox and have not been vaccinated against varicella or to immunosuppressed/immunodeficient individuals
* Household or workplace exposure to children 18 months and younger who have not been vaccinated against varicella
* Prior history of herpes zoster
* Prior receipt of any varicella or zoster vaccine
* Received or is expected to receive immune globulin and/or blood products from 5 months prior to randomization through 42 days after vaccination
* On immunosuppressive therapy
* Known or suspected immune dysfunction
* Received a live virus vaccine or is scheduled to receive a live virus vaccine from 4 weeks prior to study vaccination through the completion of all study visits
* Received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days prior to study vaccination through 7 days postvaccination, except for inactivated influenza vaccine
* Not ambulatory
* Pregnant or breastfeeding
* Use of nontopical antiviral therapy with activity against herpes viruses
* Active untreated tuberculosis

Answer: D