Clinical Drug Experience Knowledgebase

Criteria

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