Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older
Brief Summary: The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults


Options:
A: 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.
B: Inclusion Criteria:

* Pregnant women age \> 18 years to \< 39 years.
* Gestational age ≥ 20 weeks to \< 34 weeks documented by the approximate date of the last menstrual period and corroborated by physical exam.
* Documented to be HIV-infected on two assays prior to study-enrollment.
* Able to understand and comply with planned study procedures.
* Provides written informed consent prior to initiation of study.

Exclusion Criteria

* In HIV-infected women features of WHO clinical category 3 or 4 of AIDS at the time of enrollment.
* Receipt of TIV, other than through the study, during the current influenza season documented by medical history or record.
* Receipt of any live licensed vaccine ≤ 28 days or inactivated licensed vaccine ≤ 14 days prior to study-vaccine.
* Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) ≤ 28 days prior to vaccination in this study, or expects to receive another non-licensed agent before delivery unless study approval is obtained.
* Any significant (in the opinion of the site investigator) acute illness and/or oral temperature greater than or equal to 38 degrees C ≤ 24 hours prior to study entry.
* Use of anti-cancer systemic chemotherapy or radiation therapy ≤ 48 weeks of study enrollment, or has immunosuppression as a result of an underlying illness or treatment.
* Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) ≤ 12 weeks of study entry, or high-dose inhaled steroids (\> 800 mcg/day of beclomethasone dipropionate or equivalent) ≤ 12 weeks before study entry (nasal and topical steroids are allowed).
* Receipt of corticosteroids for preterm labor ≤ 14 days before study entry.(ix) Receipt of immunoglobulin or other blood products (with exception of Rho D immune globulin) ≤ 12 weeks prior to enrollment in this study or is scheduled to receive immunoglobulin or other blood products (with the exception of Rho D immune globulin) during pregnancy or for the first 24 weeks after delivery.
* Receipt of IL2, IFN, GMCSF or other immune mediators ≤ 12 weeks before enrollment.
* Uncontrolled major psychiatric disorder.
* History of a severe adverse reaction to previous TIV.
* Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
* Pregnancy complications (in the current pregnancy) such as pre-term labor, hypertension (systolic blood pressure ≥ 140 and/or diastolic blood pressure ≥ 90 mm Hg) or pre-eclampsia
C: Inclusion Criteria:

* Male or female aged 18 and older, inclusive, at the time of providing informed consent.
* Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.

Exclusion Criteria:

* Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine.
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