Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Two Part Study to Investigate the Safety and Immunogenicity of the VAX125 Influenza Vaccine in Healthy Adults Age 18-49 Years Part I: Phase I, Open-Label, Escalating Dose-Ranging Study Part II: Phase II, Double-Blind Placebo-Controlled Study
Brief Summary: Is VAX125 safe at doses ranging from 0.1 to 8 ug when delivered i.m. in a single dose regimen Is VAX125 able to induce a post-vaccination serum HAI antibody response in healthy adults against the influenza A virus H1 HA.


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:

* 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
C: 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.
D: Inclusion Criteria:

* Healthy male volunteers, 18-50 years
* Immune status: seronegative with respect to the applied virus antigens with antibody titres \<1:10 detected in the HAI assay with the corresponding antigens)
* Written informed consent to participate in this study

Exclusion Criteria:

* Acute febrile illness (\>37.3°C)
* Signs of acute or chronic upper or lower tract respiratory illnesses (sneezing, cough, tonsillitis, otitis etc.)
* History of severe atopy
* Seasonal influenza vaccination 2005/2006, 2006/2007 and/or 2007/2008 and/or pandemic influenza vaccination against H5N1
* Known increased tendency of nose bleeding
* Volunteers with clinically relevant abnormal paranasal anatomy
* Volunteers with clinically relevant abnormal laboratory values
* Simultaneous treatment with immunosuppressive drugs incl. Corticosteroids (≥2 weeks) within 4 weeks prior to study medication application
* Clinically relevant history of renal, hepatic, GI, cardiovascular, haematological, skin, endocrine, neurological or immunological diseases
* History of leukaemia or cancer
* HIV or Hepatitis B or C seropositivity
* Volunteers who underwent rhino or sinus surgery, or surgery of another traumatic injury of the nose within 30 days prior to application of study medication
* Volunteers who have received antiviral drugs, treatment with immunoglobulins or blood transfusions, or an investigational drug within four weeks prior to study medication application
* Volunteers who have received anti-inflammatory drugs 2 days prior to study medication application
* Volunteers who are not likely to cope with the requirements of the study or with a significant physical or mental condition that may interfere with the completion of the study

Answer: A