Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Single Centre, Randomised, Double Blind, Phase 1 Study of the Safety, Tolerability, and Immunogenicity of an Influenza Vaccine Candidate (FLU-v)
Brief Summary: The purpose of this study is to see whether a single vaccination (injection) with the investigational influenza vaccine is safe in healthy subjects. The study is also designed to evaluate four different dose formulations of the vaccine to see which gives the best immune response.


Options:
A: 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
B: Inclusion Criteria:

* Pregnant women age 18 years to less than 39 years.
* Gestational age greater than or equal to 20 weeks to less than 34 weeks documented by the approximate date of the last menstrual period and corroborated by physical exam.
* Documented to be HIV-1 uninfected on two assays used in the PMTCT program undertaken within 12 weeks of study enrolment.
* Able to understand and comply with planned study procedures.
* Provides written informed consent prior to initiation of study.

Exclusion Criteria:

* 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 less than or equal to 28 days or inactivated licensed vaccine (except for tetanus toxoid vaccine) less than to equal to 14 days prior to study-vaccine.
* Participants in the nested immunogenicity cohort cannot receive ANY vaccine (including tetanus toxoid) within 14 days of the study-vaccine.
* Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) less than or equal to 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.
* 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) and pre-eclampsia.
C: Inclusion Criteria:

* Subject must have a BMI \>18.5 and ≤ 28.5 kg/m2.
* Subject must have no clinically significant abnormal findings, as judged by the Investigator, on the physical examination, ECG, medical history or clinical laboratory results during screening.
* Subject must be a non-user of tobacco products, or smoke ≤ 10 cigarettes per day (minimum 6 months prior to first dose).
* Subject must have a negative urine screen for drugs of abuse and a negative alcohol breath test at screening and check-in.
* Subject must refrain from consuming alcohol for 72 hours prior to each dose.
* Subject must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator.
* Subject must give voluntary written informed consent to participate in this trial.

Exclusion Criteria:

* Subject must not have previous influenza vaccination within the 12 months prior to test drug vaccination.
* Subject must not have had an influenza like illness within the 3 months prior to test drug vaccination.
* Subject must not have a history or presence of significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, haematological or renal disorder.
* Subject must not have an oral temperature \>38°C on day of vaccination (otherwise subject maybe be re-assigned to a subsequent cohort).
* Subject must not suffer from an inherited or acquired immunodeficiency.
* Subject must not suffer from a disease or be undergoing treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (\>800µg/day beclometasone or equivalent), radiation treatment, cytotoxic drugs or non-steroidal anti-inflammatory drugs.
* Subject must not have a serologically positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
* Subject must not have a history of severe allergic reactions and/or anaphylaxis.
* Subject must not have any arm rash or tattoos which could confound the interpretation of any injection site reactions.
* Subject must not have participated in a previous clinical trial within 90 days prior to the first vaccination.
* Subject must not have donated blood or plasma more within 90 days prior to the first vaccination.
* Subject must not have donated bone marrow within 6 months prior to the first dose.
* Subject must not have received administration of immunoglobulins and/or any blood products within 90 days prior to the first vaccination, or any planned administration during the study period.
* Subject must not use any prescription medication within 14 days prior to the first vaccination.
* Subject must not use over-the-counter (OTC) medication 7 days prior to the first vaccination. Exceptions are described below under the heading 9.4.1.
* Subject must not have received any vaccine within the 30 days prior to the first dose, and must agree not to receive any other vaccine (other than any vaccine indicated for standard of care, for example, tetanus vaccine) for the duration of this study i.e 21 days post initial FLU-v vaccination.
* Subject must not have a history of alcohol or drug abuse within 2 years prior to the first dose.
* Subject must not have any condition which, in the judgement of the Investigator, precludes inclusion into the study.
* Subjects must not donate sperm up to 90 days postdose, and those whose partner is of child-bearing potential will be advised to remain sexually inactive or use a dual method of birth control (e.g. condom together with spermicidal agent, IUD or hormonal contraception) for at least 90 days postdose.
* Subject must not be a direct employee of the study site, monitoring CRO or Sponsor.
D: Inclusion Criteria:

* 18 years to 45 years
* Pregnancy between 22 and 32 weeks of gestation
* Provides written informed consent
* Covered by French Social Security

Exclusion Criteria:

* Allergy to eggs or other components in the vaccine
* History of severe reactions following previous influenza vaccines
* H1N1 influenza (virologically documented) during the last 6 months
* Febrile episode within one week prior to vaccination
* Known HIV, HBV, HCV infection
* Multiple sclerosis
* History of Guillain-Barré syndrome
* Organ transplant recipient
* Neoplastic disease in the past 3 years
* Other vaccine within 3 weeks prior to study entry or planned within the month following the last injection
* Systemic corticosteroids,immunotherapy,chemotherapy
* Anticoagulant treatment
* Immunoglobulin or blood transfusion within the 3 months prior to enrollment in this study
* History of cardiac disease
* Chronic liver disease
* Diabetes before pregnancy
* History of premature delivery
* History of eclampsia
* Fetal morphologic abnormalities

Answer: C