Please select the eligibility criteria that correspond to the clinical trial below.
Title: Trivalent Influenza Vaccine in HIV-infected Pregnant Women and Kinetics of Transplacental Anti-influenza Antibody Transfer and Persistence in Young Infants: A Randomized Controlled Phase II Trial Evaluating Safety and Immunogenicity
Brief Summary: This randomized, placebo controlled trial will evaluate the safety and immunogenicity of Trivalent Influenza Vaccine (TIV) in HIV-infected pregnant women, dynamics of transplacental anti-influenza antibody transfer to their newborns and kinetics thereof during early infancy.


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:

* 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)
C: Inclusion Criteria:

* Subjects 18 years of age and older who were mentally competent and who had signed an informed consent form after having received a detailed explanation of the study protocol;
* In good health as determined by:

  1. medical history,
  2. physical examination,
  3. clinical judgment of the Investigator;
* Able to understand and comply with all study procedures and to complete study diaries, could be contacted, and were available for study visits;

Exclusion Criteria:

* Receipt of another investigational agent within 4 weeks;
* Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
* Receipt of influenza vaccination for current season 2008/2009;
* Experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) within the past 7 days;
* Experienced fever (defined as axillary temperature ≥38.0°C) within 7 days prior to Visit 1;
* Pregnant or breastfeeding;
* Females of childbearing potential who were sexually active and had not used or did not plan or refused to use an acceptable method of birth control during the active phase of the study (at least up to three weeks after last vaccine injection);
* Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis); diabetes mellitus type I and type II; diabetes relating to genetic defects/syndromes, diseases of the exocrine pancreas or infections; advanced arteriosclerotic disease; severe chronic obstructive pulmonary disease (COPD), i.e. GOLD stages 3 and 4; acute or progressive hepatic disease and renal disease; congestive heart failure; Body Mass Index (BMI) ≥35 kg/m2 where BMI reflects obesity and not high muscle mass;
* History of progressive or severe neurologic disorders, of any neurological symptoms or signs, or anaphylactic shock following administration of any study vaccine;
* Bleeding diathesis;
* Surgery planned during the study period;
* Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccines;
* Known or suspected impairment/alteration of immune function, for example, resulting from:

  1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy) or other immunosuppressive agents within the past 60 days and for the full length of the study;
  2. receipt of immunostimulants;
  3. receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
  4. suspected or known HIV infection or HIV-related disease;
* Receipt of non study vaccines (with the exception of post-exposure vaccination in a medical emergency, e.g. hepatitis, rabies, tetanus) within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination;
* History of (or current) drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of study objectives;
* Members of research staff and their relatives;
* Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
D: 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

Answer: D