Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Brief Summary: The purpose of this study is to evaluate the absolute (versus placebo) and relative (one vaccine compared to the other) efficacies of the live attenuated and inactivated influenza vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating strains whether similar or dissimilar to strains included in the vaccines.


Options:
A: 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
B: Inclusion Criteria:

* Healthy adult men and women
* Age 18-49 years
* Who reside geographically close to one of the four study sites in Michigan

Exclusion Criteria:

* Persons with any of the health conditions for which the inactivated vaccine is recommended
* Persons for whom either vaccine is contraindicated
C: Inclusion Criteria:

* Mothers from 18 to 14 years of age in the third trimester of pregnancy,
* with normal medical and obstetric history,
* who plan to deliver their infant in Dhaka city and remain there for 12m

Exclusion Criteria:

* Maternal history of systemic disease,
* Maternal history of previous complicated pregnancies, preterm delivery, abortions, or birth with congenital anomalies.
* Maternal hypersensitivity to any vaccination, or
* Maternal receipt of pneumococcal vaccine in the last 3 years.
D: Inclusion Criteria:

* Subjects resident in Emilia-Romagna and either registered with the AUSL of Reggio Emilia, Bologna, Modena and Parma or working in the province of Reggio Emilia, Bologna, Modena and Parma included in the target groups described in the Study Protocol vaccination with H1N1sw vaccine Focetria is recommended - according to the national pandemic plan adopted at the local level - will be eligible for enrolment.

Exclusion Criteria:

* Subjects already vaccinated with another pandemic vaccine or with known contraindications to Focetria, will be excluded from this study.
* Patients institutionalized in Hospital, Nursing Homes, Rehabilitation Centers, as well as home-cared patients, will also be excluded.

Answer: B