Please select the eligibility criteria that correspond to the clinical trial below.
Title: Double Blind, Placebo Controlled Phase 3 Study of the Efficacy of an Investigational Vero Cell-Derived Influenza Vaccine (VCIV) to Prevent Culture Confirmed Influenza Infection (CCII)
Brief Summary: The primary purpose of this study is to demonstrate the efficacy of an investigational Vero-cell derived influenza vaccine to prevent infection in an adult population with an influenza virus that is antigenically similar to one of the three strains in the vaccine. All subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will be monitored for 180 days following vaccination for occurrence of adverse events. For determining antibody response, subjects will have one blood draw before and one blood draw 21 days after vaccination.


Options:
A: Inclusion Criteria:

* A male or female age between 18 and 64 years at the time of the first vaccination.
* non-childbearing female

Exclusion Criteria:

* Use of non-registered products
* Pregnancy
* Hypersensitivity to a previous dose of influenza vaccine
* Acute disease at the time of enrolment/vaccination.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine
* Administration of any other influenza vaccine for the season 2006-2007
* Chronic disorders of the pulmonary or cardiovascular system, including asthma.
* Administration of immune-modifying drugs
* Administration of immunoglobulins and/or any blood products
* History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, asthma or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus)
B: Inclusion Criteria:

* Healthy male or female aged 18 - 49 years or \>= 65 years
* Give written informed consent
* Females have a negative urine test for pregnancy before vaccination and use birth control during 28 day study period
* Willing to receive the unlicensed (VAX128) vaccine given as an i.m. injection
* Willing to provide multiple blood specimens collected by venipuncture

Exclusion Criteria:

* Chronic illness that would interfere with the subject's participation in the study or interpretation of the study results.
* Impaired immune responsiveness
* Received drugs effecting the immunity
* Received or plan to receive a nonstudy vaccine within 30 days prior to vaccination and during the study, including licensed influenza vaccines.
* History of anaphylactic type reaction to injected vaccines.
* History of drug abuse in the year prior to screening.
* History of Guillain-Barré Syndrome.
* Receipt or donation of blood products
* Acute disease within 72 hours prior to vaccination
* History of heart or lung disease
* Has other conditions that might interfere with study objectives.
C: Inclusion Criteria:

Male and female subjects who

* are 18 to 49 years of age, inclusive, on the day of screening
* have an understanding of the study, agree to its provisions and give written informed consent prior to study entry
* If female and capable of bearing children - have a negative urine pregnancy test result within 24 hours of the vaccination on Study Day 0 and agree to employ adequate birth control measures. For the purposes of this study adequate birth control measures incorporate two types of the following FDA approved birth control measures through 60 days after the vaccination: hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, OR an additional barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.).

Exclusion Criteria:

Subjects who have any of the risk factors for complications from influenza infection as defined by the Centers for Disease Control and Prevention (CDC):

* pregnancy
* chronic disorders of the pulmonary or cardiovascular system including asthma (hypertension is not considered a high risk condition)
* chronic renal disorders
* chronic hepatic disorders
* chronic hematological disorders
* chronic metabolic disorder (including diabetes mellitus)
* immunosuppression (including immunosuppression caused by medications or HIV)
* any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase risk for aspiration (e.g., cognitive dysfunction, spinal cord injuries, seizure disorders or other neuromuscular disorders)
* residence in a nursing home or other chronic care facility that houses persons of any age who have chronic medical conditions
* household contact with children aged 0 to 59 months or of someone who is included in the risk categories listed above
* employment as a health care worker

Subjects are also excluded if they

* are unable to lead an independent life as a result of either physical or mental handicap
* have a history of severe allergic reactions or anaphylaxis
* have an oral temperature of \>= 99.5° F (37.5°C) on the day of vaccination in this study. \[NOTE: Subjects meeting this exclusion criterion may be rescheduled for vaccination and study entry at a later date provided: 1.) oral temperature has decreased to \< 99.5°F (37.5°C) on rescheduled date, 2.) all other inclusion/exclusion criteria are met, 3.) the rescheduled date is no more than 14 days past the initial screening date, 4.) the study site is still enrolling subjects\]
* have a rash or dermatologic condition or tattoos which may interfere with injection site reaction rating
* have received a blood transfusion or immunoglobulins within 90 days of study entry
* have received a live vaccine within 4 weeks or inactivated vaccine within 2 weeks of study entry
* have previously been vaccinated against influenza for the 2007/2008 northern hemisphere influenza season
* have functional or surgical asplenia
* have a known or suspected problem with alcohol or drug abuse
* were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
* are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, spouse/partner, siblings, parents) as well as employees of the investigator.
D: Inclusion Criteria:

1. subjects 18 to 49 years of age;
2. in good health as determined by medical history and physical examination;
3. able and willing to provide written informed consent prior to any study procedure;
4. able to comply with all study procedures, including availability and willingness to be actively followed throughout the ensuing influenza season with weekly telephone calls and to comply with the need for prompt collection of nasal and throat specimens in the event of influenza symptoms.

Exclusion Criteria:

1. history of anaphylaxis or serious reaction after administration of any vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, kanamycin, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
2. any health condition for which the inactivated vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP) including chronic diseases of the pulmonary or cardiovascular systems (including asthma), chronic metabolic diseases (including diabetes), renal dysfunction, hemoglobinopathies, immune deficiency disease (including HIV infection) or on-going immunosuppressive therapy;
3. employment in professions prone to influenza transmission to or from high-risk populations (this exclusion specifically includes nurses, physicians, all other healthcare workers with direct patient contact; and police, fire, and rescue personnel); or living in the same household as an immunocompromised person;
4. history of Guillain-Barré syndrome;
5. bleeding diathesis;
6. receipt of another investigational agent within 90 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end of the study;
7. receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
8. laboratory-confirmed influenza disease within 6 months prior to Visit 1;
9. receipt of an influenza vaccine within 6 months prior to Visit 1 or plans to receive influenza vaccine outside of this study;
10. experienced a temperature (≥100.0°F / ≥37.8°C) and/or any acute illness within 3 days prior to study vaccination;
11. pregnant or breast-feeding female;
12. if female of childbearing potential and sexually active, has not used any of the birth control methods detailed in the section entitled "Females of Childbearing Potential" for at least 2 months prior to study entry;
13. if female of childbearing potential and sexually active, refusal to use a reliable contraceptive method as detailed in the section entitled "Females of Childbearing Potential" during the first 3 weeks after vaccination;
14. research staff directly involved with the clinical study or family members or household members of research staff. Research staff are individuals with direct or indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.;
15. any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or with the safety of the study subject.

Answer: C