Please select the eligibility criteria that correspond to the clinical trial below.
Title: Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A(H1N1)v Chez la Femme Enceinte
Brief Summary: The purpose of this study is to evaluate the immunogenicity and safety of an inactivated, non adjuvanted A(H1N1)v influenza vaccine in 120 pregnant women.

Study procedures will include 2 doses of vaccine, blood samples, cord blood samples at delivery and recording temperature and vaccine side effects in a memory aid for 7 days following each vaccination. Participants will be involved in study related procedures about 3 at 5 months.


Options:
A: 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
B: Inclusion Criteria:

* A male or female age between, and including, 18 and 64 years of age at the time of the vaccination.
* Written informed consent obtained from the subject.
* Availability to follow up by phone during the study period.
* Female subjects must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal. If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after vaccination.

Exclusion Criteria:

* History of hypersensitivity to a previous dose of influenza vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate.
* Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature \< 37.5°C).
* Pregnancy
* Chronic disorders of the pulmonary or cardiovascular system, including asthma
* History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus.
C: Inclusion Criteria:

* Age 18-49 years
* Available for clinic visits at Tufts-New England Medical Center
* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) obtained
* Ability of participant to understand and comply with the requirements of the protocol

Exclusion Criteria:

* History of any medical conditions for which the CDC states should not be vaccinated with LAIV (asthma, reactive airways disease, other chronic disorders of the pulmonary or cardiovascular systems; metabolic diseases such as diabetes, renal dysfunction, and hemoglobinopathies; or persons with known or suspected immunodeficiency diseases)
* Self-reported vaccination with the influenza vaccine for the current influenza season (2007-8); vaccination with any vaccine within the one month period prior to study enrollment or intent to receive any other vaccine during the study period; hypersensitivity to any influenza vaccine components including thimersol or egg or Guillain-Barre syndrome
* Self-reported treatment with immunomodulator/immunosuppressor drugs (interleukins, corticosteriods (oral or inhaled)), G(M)-CSF in 4 weeks before enrollment or self-reported history of IL-2 administration within 5 years; use of theophylline preparations or warfarin because of the theoretical possibilities of enhanced drug effects and toxicities following influenza vaccination; medication use that might affect the immune response to a vaccine or effects of LGG (no antibiotics during the previous 4 weeks)
* Current alcohol, substance abuse, or systemic/psychiatric illness that potentially could interfere with compliance and ability to make study visits
* Health care or day care workers or close contacts with immunosuppressed persons because of the theoretical risk that LAIV could be transmitted to the immunosuppressed person and cause disease, per CDC recommendations
* Use of LGG or other probiotics in 4 weeks before enrollment. Yogurt consumption is not an exclusion criteria, but subjects will be asked to avoid consumption of other lactobacilli and probiotic organisms during the study period
* Abnormalities upon physical examination
* Acute febrile illness on day of intended immunization - immunization deferred until illness resolved
* Routine laboratory tests outside the limits outlined for this study:

  1. hemoglobin \>=11.5g/dL for women; \>=13.5 g/dL for men
  2. WBC 3,300-12,000 cells/mm\^3
  3. Differential within normal range
  4. Platelets 125,000-550,000 /mm\^3
  5. ALT \<= upper limit of normal
  6. Serum creatinine \<= upper limit of normal
  7. Normal urinalysis (negative glucose, negative or trace protein, and negative or trace hemoglobin)
  8. Negative beta-HCG pregnancy test (urine or serum) for women presumed to be of reproductive potential because LAIV is contraindicated in pregnant women
  9. negative HIV test
  10. negative hepatitis B surface antigen
  11. negative anti-HCV
D: Inclusion Criteria:

* Adults aged 50 to 64.
* Females should be at least 2 years post-menopausal or sterile or practicing accepted form of birth control (including: condom with spermicidal, licensed hormonal contraceptive, abstinence, IUD or monogamous relationship with a vasectomized partner).
* Healthy, as determined by oral temperature \<100.0°F, medical history, and medical assessment w/ brief physical evaluation by RN (if indicated) based on medical history.
* Able to understand and comply with planned study procedures.
* Provides written informed consent prior to initiation of any study procedure.

Exclusion Criteria:

* Known allergy to eggs or other vaccine components.
* Immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.
* Any malignancy other than localized prostate cancer, diagnosed or treated actively during the past 5 years. Exceptions: Subjects with a history of lymphoproliferative disorder at any time in their life will be excluded, while subjects with a history of localized nonmelanotic skin cancer that has been completely removed during the past 5 years may be eligible.
* Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (Nasal and topical steroids are allowed).
* Diagnosis of or treatment for bipolar disorder, severe major depression, schizophrenia or other major psychotic disorder in the past 3 months that is associated with severely impaired judgment or cognition.
* History of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
* Receipt of any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
* Use of experimental vaccines or any influenza vaccine other than FluBlOk after May 31st 2007 for the 2008 Southern Hemisphere or 2007 to 2008 Northern hemisphere epidemic seasons.
* History of severe reactions following immunization with influenza virus vaccines.
* Moderate to severe acute illness or febrile illness (oral temperature greater than 100degreesF) within 1 week prior to vaccination.
* Receipt of an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during study period.
* Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
* History of alcohol or drug abuse in the last 5 years.
* History of Guillain-Barré Syndrome.
* Subject is not available for three (3) or more consecutive weeks during active influenza season.
* Any acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, interfere with the evaluation of responses, or render the subject unable to meet the requirements of the protocol. These conditions include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long there has been no dosage increase within the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Heart Association Functional Class III or IV); an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack)

Answer: A