Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparative Study of Influenza Vaccines in Adults - FLU-VACS
Brief Summary: The purpose of this study is to compare 2 licensed flu vaccines to each other and to placebo (inactive substance). The study will be conducted among healthy adult participants aged 18-49 years and is expected to last 3 years. During year 1, participants will be assigned to receive 1 of the 2 licensed flu vaccines or placebo, given as either nasal spray (live-attenuated vaccine or placebo) or injection (inactivated vaccine or placebo). Participants will receive the same assigned vaccine or placebo during year 2. During year 3, participants will be followed, but will not receive flu vaccine. Each year blood samples will be collected before and 1 month after each vaccination and at the end of each flu season in order to measure how the body responds to the vaccine and how well participants were protected from the flu. During the flu season, participants with flu-like illness will provide information on symptoms and provide a throat swab to test for virus identification.


Options:
A: Inclusion Criteria:

* Male or female aged 18 - 49 years inclusive
* Give written informed consent to participate.
* Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations
* Females should willing to use another reliable form of contraception approved by the Investigator and a negative urine pregnancy test within 24 hours preceding receipt of vaccination
* Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.

Exclusion Criteria:

* Presence of significant uncontrolled medical or psychiatric illness (acute or chronic). This includes institution of new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed on Day 0 prior to vaccination.
* Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies.
* Cancer, or treatment for cancer, within 3 years. (Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible), excluding basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) which is allowed, unless at vaccination site.
* Impaired immune responsiveness (of any cause), including diabetes mellitus.
* Documented influenza infection with a positive culture in the 6 months prior to screening.
* Presently receiving or history of receiving any medications or treatments that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) in the past 6 months prior to screening. Inhaled and topical corticosteroids will be allowed.
* Receipt or planned administration of a nonstudy vaccine within 30 days prior to vaccination and during the study, including licensed influenza vaccines. Immunization on an emergency basis with Tetanus Toxoid Adsorbed for adult use (Td or Tdap) up to 8 days before or at least 8 days after a dose of study vaccine will be allowed. Administration of study vaccine injection can be delayed if a nonstudy vaccine has been administered and will be given as soon as acceptable, as described above, provided the vaccine is not administered within two weeks prior to study enrollment.
* History of anaphylactic type reaction to injected vaccines.
* History of drug or chemical abuse in the year before the study.
* Receipt of any investigational product or nonregistered drug within the 30 days prior to vaccination or currently enrolled in any investigational drug study or intends to enroll in such a study within the ensuing study period.
* Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the study period.
* Donation of blood or blood products within 8 weeks prior to vaccination or at any time during the study.
* Acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination; for example, those requiring an absence from work) with or without fever, or a fever \>37.9ºC orally. Study vaccine can be administered to persons with a minor illness, such as diarrhea, or mild upper respiratory tract infection with or without low-grade febrile illness. Vaccination can be delayed until the subject has recovered.
* Any condition that, in the opinion of the investigator, might interfere with study objectives
B: Inclusion Criteria:

* Health adults of both genders
* Age ≥ 18 ≤ 50 years
* Able to understand every required study procedure
* Female volunteers should agree to take an acceptable contraceptive method Menopause is characterized by absence of menstrual flux for two consective years
* Normal values for pre-stablished laboratory assays
* Accpetance to participate and sign the consent form

Exclusion Criteria:

* Any chronic condition
* Be on immunossupressive or stimulant therapy
* Have egg alergy
* Have past history of alergy to sazonal influenza vaccine
* Have received another inactivated vaccine within the prior 2 weeks or a live vaccine in the past four weeks to his/her participation in the study
* Acute infectious disease during seven days prior vaccination
* Female on breasthfeeding
* Confirmed prior infection by pandemic influenza A
* Participation in another clinical trial in the last 6 months
* Any other condition identified by the principal investigator which is considered not safe for enrollment of the volunteer
C: Inclusion Criteria:

* Persons must be adult men and women aged 18-49 years.
* Persons must be able and willing to provide informed consent.
* Persons must expect to reside in the study area during the entire study period and be interested in participating each year.
* Persons must be willing to receive the licensed live-attenuated vaccine (FluMist) or placebo given as a nasal spray, or the licensed inactivated influenza vaccine (Fluzone or Fluvirin) or placebo given as an intramuscular injection.
* Persons must be willing to provide multiple blood specimens collected by venipuncture each year they are in the study. During each of the first two years of study, blood specimens will be collected three times - at the enrollment visit (immediately prior to administration of vaccine or placebo), at the first follow-up visit 3-5 weeks later, and at the end of the influenza season visit (approximately 4-6 months later); during the third year of the study, blood specimens will be collected twice only, at visits before and after the influenza season.
* Persons must be willing to notify study personnel in the event of influenza-like illness, to provide information on illness symptoms, and to permit collection of a throat culture (swab) specimen for laboratory studies.
* Persons must be willing to not receive an influenza vaccine while participating - other than that (influenza vaccine or placebo) received as study medication.

Exclusion Criteria:

* Persons with any health condition for which the inactivated vaccine is recommended (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.
* Persons who are currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination.
* Persons with hypersensitivity to egg, egg protein, thimerosal (a preservative) or the antibiotic Gentamicin (also know as Garamycin).
* Persons who have had a prior serious reaction to influenza vaccine, or ever had Guillain-Barre syndrome.
* Persons who are living in a household with or have direction occupational contact with immunosuppressed individuals (including health care workers with direct patient contact).
* Persons who have received an influenza vaccine for the influenza season in which they are to be first enrolled or those who plan to receive an influenza vaccine during their participation in the study - other than that (influenza vaccine or placebo) received as study medication.
* Persons who have received any other vaccine within one week prior to enrollment (may delay enrollment).
* Persons who have had a respiratory illness or illness with fever within 3 days of study enrollment (may delay enrollment).
* Persons who are participating in another research study involving any study medications (medicines or vaccines).
D: Inclusion Criteria:

1. Healthy pregnant women
2. Be able to show legal identity card for the sake of recruitment
3. Be able to understand and sign the informed consent

Exclusion Criteria:

1. Cases, cured cases and close contact of influenza A (H1N1) virus
2. Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
4. Autoimmune disease or immunodeficiency
5. Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
6. Diabetes mellitus (type I or II), with the exception of gestational diabetes
7. History of thyroidectomy or thyroid disease that required medication within the past 12 months
8. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
9. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
10. Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
11. History of any blood products or seasonal influenza vaccine administration within 3 months before the dosing
12. Administration of any other investigational research agents within 30 days before the dosing
13. Administration of any live attenuated vaccine within 30 days before the dosing
14. Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
15. Axillary temperature \> 37.0 centigrade at the time of dosing
16. Psychiatric condition that precludes compliance with the protocol
17. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

Answer: C