Immunogenicity of H5N1 Vaccine Following H5N2
Immunogenicity of H5N1 Vaccine Following H5N2
This study is designed to assess whether a live attenuated Influenza vaccine (LAIV) can
 induce a long-lasting immune memory by comparing the immunologic response to two doses of the
 OrniFlu® inactivated vaccine given to subjects previously primed with LAIV and subjects who
 did not received LAIV.
This study evaluated immunogenicity of an adjuvanted A(H5N1) inactivated influenza vaccine
 (IIV) in healthy adult subjects who received A(H5N2) live attenuated influenza vaccine (LAIV)
 1.5 years earlier (September/October 2012) and compared this with a group of naive subjects
 that did not participate in the previous study. Inclusion/exclusion criteria for the
 additional group of naive volunteers mirrored those utilized in the initial study.
Inclusion Criteria:

 -  Legal male or female adult 18 through 51 years of age at the enrollment visit

 -  Literate and willing to provide written informed consent

 -  A signed informed consent

 -  Free of obvious health problems, as established by the medical history and screening
 evaluations, including physical examination

 -  Capable and willing to complete a memory aid and willing to return for all follow-up
 visits

 -  For females, willing to take reliable birth control measures through Day 56

 Exclusion Criteria:

 -  Participation in another clinical trial involving any investigational agent within the
 previous three months or planned enrollment in such a trial during the period of this
 study

 -  Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to
 postpone receipt

 -  Participation in any other clinical trials involving any H5-matched influenza vaccines
 except that in Protocol LAIV-H5N2-01

 -  Current or recent (within two weeks of enrollment) acute respiratory illness with or
 without fever

 -  Other acute illness at the time of study enrollment

 -  Receipt of immunoglobulin or other blood products within three months prior to study
 enrollment or planned receipt during study period

 -  Chronic administration (defined as more than 14 consecutively-prescribed days) of
 immunosuppressants and/or immune-modulating therapy within six months prior to study
 enrollment

 -  History of bronchial asthma

 -  Hypersensitivity after previous administration of any (not only influenza) vaccines.

 -  Other adverse event (AE) following immunization at least possibly related to previous
 receipt of any (not only influenza) vaccine

 -  Suspected or known hypersensitivity to any of the study vaccine components, including
 protein of chicken eggs

 -  Seasonal (autumnal) hypersensitivity to the natural environment

 -  Acute or chronic clinically significant abnormality, as determined by medical history,
 physical examination or clinical laboratory screening tests, which in the opinion of
 the investigator, might interfere with the study objectives. Subjects with physical
 examination findings or clinical laboratory screening results which would be graded 2
 or higher on the AE severity grading scale will be excluded from entry into the study

 -  History of leukemia or any other blood diseases or solid organ cancer

 -  History of thrombocytopenic purpura or known bleeding disorder

 -  History of seizures

 -  Known or suspected immunosuppressive or immunodeficient condition of any kind,
 including HIV infection

 -  Known chronic hepatitis B virus (HBV) or hepatitis C (HCV) infection

 -  Known tuberculosis infection or evidence of previous tuberculosis exposure

 -  History of chronic alcohol abuse and/or illegal drug use

 -  Pregnancy or lactation.

 -  Systemic connective tissue disorders

 -  Adrenal gland diseases

 -  Hereditary, degenerative and progredient diseases of the nervous system

 -  Any condition that, in the opinion of the investigator, would increase the health risk
 to the subject if he/she participates in the study or would interfere with the
 evaluation of the study objectives

 -  Allergic, including anaphylactic, reactions to any (not only influenza) vaccines