Please select the eligibility criteria that correspond to the clinical trial below.
Title: Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adult and Elderly Subjects
Brief Summary: The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine.

Primary Objectives:

* To describe the immunogenicity of the candidate vaccines after each injection.
* To describe the safety of the candidate vaccines after each injection.


Options:
A: 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
B: Inclusion Criteria:

* Good health by history and physical exam
* Reliable access to a telephone
* Study comprehension and informed consent

Exclusion Criteria:

* Systolic BP \>/= 140; diastolic BP \>/= 90
* Uncontrolled medical or psychiatric illness (change in last 3 months)
* Cancer, or treatment for cancer within 3 years
* Cardio-pulmonary disease requiring chronic treatment
* Insulin dependent diabetes mellitus
* Renal dysfunction (creatinine \>/= 1.7 mg/dL)
* Hemoglobinopathies
* Clotting disorders that increase the risk of IM injections
* Immunosuppressive illnesses or drugs
* History of demyelinating disease (esp. Guillian-Barre syndrome)
* Employment in professions at high risk for influenza transmission
* Household contact with high-risk individuals
* Receipt of:

  a) Immunosuppressive drugs i) systemic glucocorticoids \>/= 10 mg prednisone per day ii) cytotoxic drugs b) Investigational drugs within 30 days before, or planned during, the study c) Blood products within 3 months before, or planned during, the study d) Influenza vaccine within 9 months before the study e) Other vaccines within 30 days before, or planned during, the study
* History of:

  1. Severe reactions to other influenza vaccines
  2. Allergy to egg proteins
  3. Sensitivity to mercurials
* Pregnancy/ high risk of pregnancy

  1. Positive urine pregnancy test before treatment
  2. Women of child-bearing potential without credible contraceptive plan
C: Inclusion Criteria :

* Healthy adults aged 18 years or older on the day of inclusion
* Informed consent has been signed and dated
* Able to attend all scheduled visits and comply with all trial procedures
* For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.

Exclusion Criteria :

* Known pregnancy or positive urine pregnancy test
* Currently breastfeeding a child
* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
* Planned participation in another clinical trial during the present trial period
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination
* Planned receipt of any vaccine prior to the Day 42 blood sample
* Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or Hepatitis C
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
* Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
* Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
* Chronic illness that in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
* Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator.
* Previous participation in a swine-origin H1N1 pandemic flu trial except if performed in 1976
* Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
* Febrile illness (temperature ≥ 100.4°F \[≥ 38.0°C\]) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination
* Personal or family history of Guillain-Barré syndrome
* Active neoplastic disease or a history of any hematologic malignancy
* Known seizure/epilepsy history and/or taking anti-seizure medication
* Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
D: Inclusion Criteria :

All subjects:

* Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 7 to 9 years
* Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures

Subjects aged 3 to 9 years:

* Healthy children aged 3 to 9 years on the day of inclusion

Subjects aged 6 to 35 months:

* Healthy infants and toddlers aged 6 to 35 months on the day of inclusion
* Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

Exclusion Criteria :

* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
* Planned participation in another clinical trial during the present trial period
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination
* Planned receipt of any vaccine prior to the Day 42 blood sample
* Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
* Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
* Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Chronic illness that in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
* Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
* Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
* Personal or family history of Guillain-Barré syndrome
* Active neoplastic disease or a history of any hematologic malignancy
* Known seizure/epilepsy history and/or taking anti-seizure medication
* Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
* Febrile illness (temperature ≥ 100.4°F \[≥ 38.0°C\]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination

Answer: C