Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Double-Blind, Randomized, Multicenter Study to Evaluate the Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated)
Brief Summary: The study evaluated immunogenicity, safety, and tolerability of ZOSTAVAX™ Vaccine (V211) administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine (inactivated) in participants ≥50 years of age. The primary hypotheses tested 1) the noninferiority of concomitant versus nonconcomitant vaccination with regard to Varicella zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses, 2) the acceptability of geometric mean fold rise in VZV antibody response after concomitant vaccination, and 3) the noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza virus strain-specific GMT antibody responses.


Options:
A: 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 50 years or older at the time of the first vaccination;
* Female subjects of non-childbearing potential may be enrolled in the study;

For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.

OR 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 urine 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 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 enrollment;
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Pregnant or lactating female;
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
B: 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.
* 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 vaccine 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 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 (E.g. inactivated and subunit vaccines) within 8 days prior to or within 14 days after either dose of study vaccine.
* 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 product.
* Previous vaccination against HZ or varicella.
* Planned administration during the study of an HZ or varicella vaccine other than the study vaccine.
* History of HZ.
* 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 vaccine.
* Acute disease and/or fever at the time of enrollment.

  * Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic route, or ≥ 38.0°C (100.4°F) on rectal route. The preferred route for recording temperature in this study will be oral.
  * Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
* Administration of immunoglobulins and/or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
* Pregnant or lactating females.
* Females planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 4.
* Any condition which, in the opinion of the investigator, prevents the subject from participating in 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 injection unsafe.
C: Inclusion Criteria:

1. Age ≥ 70 years
2. Varicella history-positive or residence for \> 30 years in a country with endemic VZV infection
3. Signed informed consent form prior to any study procedure

Exclusion Criteria:

1. Febrile illness within the last 72 hours before the first vaccination
2. Prior herpes-zoster episode clinically diagnosed by a physician
3. Prior receipt of varicella or zoster vaccine
4. Exposure to varicella or herpes-zoster within the 4 weeks prior to the first vaccination
5. Significant underlying illness preventing completion of the study vaccination schedules,
6. Known active tuberculosis,
7. Immune deficiency disorder, including active neoplastic disease within the prior 5 years,
8. Immune function impairment caused by medical condition or immunosuppressive therapy, or any other cause,
9. Receipt of any inactivated vaccine within the 2 weeks prior to the first vaccination,
10. Receipt of any other live vaccine within the 4 weeks prior to the first vaccination,
11. Receipt of immunoglobulins or blood-derived products within the 5 months prior to the first vaccination,
12. Concomitant use of non-topical antiviral therapy
D: Inclusion Criteria:

* Has history of varicella or residence in a VZV-endemic area for ≥30 years
* Is male, female not of reproductive potential, or female of reproductive potential and has a negative pregnancy test and agrees to avoid becoming pregnant throughout the study

Exclusion Criteria:

* Has history of hypersensitivity to any vaccine component
* Has previously received any varicella or zoster vaccine
* Has received an influenza vaccine for the 2015-16 season
* Has history of Herpes zoster
* Has received immunoglobulin, monoclonal antibodies, or any blood products within 5 months before study vaccination
* Is pregnant or breastfeeding, or expecting to conceive during the study
* Has used immunosuppressant therapy
* Has known or suspected immune dysfunction
* Has experienced Guillain-Barré syndrome within 6 weeks
* Has severe thrombocytopenia or any other coagulation disorder

Answer: D