Use of any investigational or non-registered drug or vaccine product within 30 days preceding the administration of the study vaccine or planned use within the first six weeks of the study period 
Has received any licensed or other investigational influenza vaccine within 3 months prior to enrollment in this study or expected receipt of any influenza vaccination before the Day 21 blood collection 
History of excessive alcohol use, drug abuse or significant psychiatric illness 
Tobacco use within 3 months of enrollment and throughout first 6 months of the study 
Has a chronic illness (e.g., liver or kidney disease), receiving a concomitant therapy or have any other condition that could interfere with the subject's participation in the study or in the interpretation of the study results 
Clinically significant abnormal liver function tests at screening 
Positive serology for HBsAg, HCV or HIV antibodies 
Pregnant or lactating female 
Having cancer or have received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding minor skin cancers, which are allowed unless located at the vaccination site 
Persons with impaired immune responsiveness (of any cause), including diabetes mellitus and autoimmune disorders 
Persons presently receiving or having a recent history of receiving (within the past six months) any medication or therapeutic modality that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, radiation therapy, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Inhaled and topical corticosteroids are allowed. 
Persons with a history of severe allergic reaction after previous vaccinations or hypersensitivity to any seasonal influenza vaccine component 
Persons with a history of Guillain-Barré Syndrome 
Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the three week study period following vaccination 
Donation of blood or blood products within 8 weeks prior to vaccination or during the three week study period following 
An oral temperature >100.4° or 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. 
Body Mass Index >29.9 
Any disorder of coagulation 
A clinical diagnosis of influenza within the previous 12 months 
Any other condition or circumstance which, in the opinion of the Principal Investigator, poses an unacceptable risk for participation in the study       
    

NCT02015494_exc_T1
Drug
drug
NCT02015494_exc_T2
Drug
vaccine product
NCT02015494_exc_T3
Qualifier
investigational
NCT02015494_exc_T4
Qualifier
non-registered
NCT02015494_exc_T5
Scope
investigational or non-registered
NCT02015494_exc_T6
Temporal
within 30 days preceding the administration of the study vaccine
NCT02015494_exc_T7
Reference_point
the administration of the study vaccine
NCT02015494_exc_T9
Temporal
within the first six weeks of the study period
NCT02015494_exc_T10
Observation
planned use
NCT02015494_exc_T11
Reference_point
the study period
NCT02015494_exc_T12
Scope
within 30 days preceding the administration of the study vaccine or planned use within the first six weeks of the study period
NCT02015494_exc_T13
Scope
drug or vaccine product
NCT02015494_exc_T15
Drug
influenza vaccine
NCT02015494_exc_T16
Qualifier
licensed
NCT02015494_exc_T17
Qualifier
other investigational
NCT02015494_exc_T18
Scope
licensed or other investigational
NCT02015494_exc_T19
Temporal
within 3 months prior to enrollment in this study
NCT02015494_exc_T20
Reference_point
enrollment in this study
NCT02015494_exc_T21
Observation
expected receipt
NCT02015494_exc_T23
Drug
any influenza vaccination
NCT02015494_exc_T24
Temporal
before the Day 21
NCT02015494_exc_T25
Reference_point
Day 21
NCT02015494_exc_T26
Observation
History
NCT02015494_exc_T27
Condition
excessive alcohol use
NCT02015494_exc_T28
Condition
drug abuse
NCT02015494_exc_T29
Condition
psychiatric illness
NCT02015494_exc_T31
Qualifier
significant
NCT02015494_exc_T32
Scope
excessive alcohol use, drug abuse or significant psychiatric illness
NCT02015494_exc_T33
Condition
Tobacco use
NCT02015494_exc_T34
Temporal
within 3 months of enrollment
NCT02015494_exc_T35
Reference_point
enrollment
NCT02015494_exc_T36
Temporal
throughout first 6 months of the study
NCT02015494_exc_T37
Reference_point
the study
NCT02015494_exc_T38
Condition
chronic illness
NCT02015494_exc_T40
Condition
liver disease
NCT02015494_exc_T41
Condition
kidney disease
NCT02015494_exc_T42
Scope
liver or kidney disease
NCT02015494_exc_T43
Procedure
therapy
NCT02015494_exc_T44
Temporal
concomitant
NCT02015494_exc_T46
Condition
any other condition
NCT02015494_exc_T47
Qualifier
could interfere with the subject's participation in the study
NCT02015494_exc_T48
Measurement
liver function tests
NCT02015494_exc_T49
Value
abnormal
NCT02015494_exc_T50
Qualifier
Clinically significant
NCT02015494_exc_T52
Temporal
at screening
NCT02015494_exc_T53
Reference_point
screening
NCT02015494_exc_T54
Measurement
HBsAg antibodies
NCT02015494_exc_T55
Measurement
HCV antibodies
NCT02015494_exc_T56
Measurement
HIV antibodies
NCT02015494_exc_T57
Scope
HBsAg, HCV or HIV antibodies
NCT02015494_exc_T58
Value
Positive
NCT02015494_exc_T59
Condition
Pregnant
NCT02015494_exc_T60
Condition
lactating
NCT02015494_exc_T61
Person
female
NCT02015494_exc_T62
Condition
cancer
NCT02015494_exc_T63
Condition
cancer
NCT02015494_exc_T64
Procedure
treatment for cancer
NCT02015494_exc_T65
Temporal
within three years
NCT02015494_exc_T66
Scope
cancer or have received treatment for cancer
NCT02015494_exc_T67
Condition
cancer
NCT02015494_exc_T68
Observation
history
NCT02015494_exc_T69
Condition
disease-free
NCT02015494_exc_T70
Procedure
treatment
NCT02015494_exc_T71
Negation
without
NCT02015494_exc_T72
Temporal
for three years or more
NCT02015494_exc_T74
Scope
history of cancer who are disease-free without treatment for three years or more are eligible
NCT02015494_exc_T75
Condition
impaired immune responsiveness
NCT02015494_exc_T76
Condition
diabetes mellitus
NCT02015494_exc_T77
Condition
autoimmune disorders
NCT02015494_exc_T78
Scope
diabetes mellitus and autoimmune disorders
NCT02015494_exc_T79
Temporal
within the past six months
NCT02015494_exc_T80
Drug
any medication
NCT02015494_exc_T81
Procedure
therapeutic modality
NCT02015494_exc_T82
Qualifier
affects the immune system
NCT02015494_exc_T83
Drug
allergy shots
NCT02015494_exc_T84
Drug
immune globulin
NCT02015494_exc_T85
Drug
interferon
NCT02015494_exc_T86
Drug
immunomodulators
NCT02015494_exc_T87
Procedure
radiation therapy
NCT02015494_exc_T88
Drug
cytotoxic drugs
NCT02015494_exc_T89
Drug
drugs known to be frequently associated with significant major organ toxicity
NCT02015494_exc_T90
Qualifier
known to be frequently associated with significant major organ toxicity
NCT02015494_exc_T91
Drug
systemic corticosteroids
NCT02015494_exc_T92
Qualifier
oral
NCT02015494_exc_T93
Qualifier
injectable
NCT02015494_exc_T94
Scope
oral or injectable
NCT02015494_exc_T96
Scope
any medication or therapeutic modality that affects the immune system
NCT02015494_exc_T97
Scope
allergy shots, immune globulin, interferon, immunomodulators, radiation therapy, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable)
NCT02015494_exc_T98
Condition
allergic reaction
NCT02015494_exc_T99
Qualifier
severe
NCT02015494_exc_T100
Observation
history
NCT02015494_exc_T101
Temporal
after previous vaccinations
NCT02015494_exc_T102
Reference_point
previous vaccinations
NCT02015494_exc_T103
Condition
hypersensitivity to any seasonal influenza vaccine component
NCT02015494_exc_T104
Drug
seasonal influenza vaccine component
NCT02015494_exc_T105
Condition
Guillain-Barré Syndrome
NCT02015494_exc_T106
Procedure
Receipt of blood
NCT02015494_exc_T107
Procedure
Receipt of blood products
NCT02015494_exc_T108
Temporal
8 weeks prior to vaccination
NCT02015494_exc_T109
Reference_point
vaccination
NCT02015494_exc_T110
Temporal
during the three week study period following vaccination
NCT02015494_exc_T111
Reference_point
three week study period following vaccination
NCT02015494_exc_T112
Observation
planned administration
NCT02015494_exc_T113
Scope
Receipt of blood or blood products
NCT02015494_exc_T114
Scope
8 weeks prior to vaccination or planned administration during the three week study period following vaccination
NCT02015494_exc_T115
Procedure
Donation of blood
NCT02015494_exc_T116
Procedure
Donation of blood products
NCT02015494_exc_T117
Temporal
within 8 weeks prior to vaccination
NCT02015494_exc_T118
Reference_point
vaccination
NCT02015494_exc_T119
Temporal
during the three week study period
NCT02015494_exc_T120
Reference_point
the three week study period
NCT02015494_exc_T121
Scope
within 8 weeks prior to vaccination or during the three week study period
NCT02015494_exc_T122
Scope
Donation of blood or blood products
NCT02015494_exc_T123
Measurement
oral temperature
NCT02015494_exc_T124
Value
>100.4°
NCT02015494_exc_T125
Condition
acute disease
NCT02015494_exc_T126
Temporal
within 72 hours prior to vaccination
NCT02015494_exc_T127
Reference_point
vaccination
NCT02015494_exc_T128
Scope
oral temperature >100.4° or acute disease
NCT02015494_exc_T129
Condition
moderate illness
NCT02015494_exc_T130
Condition
severe illness
NCT02015494_exc_T131
Measurement
Body Mass Index
NCT02015494_exc_T132
Value
>29.9
NCT02015494_exc_T133
Condition
disorder of coagulation
NCT02015494_exc_T134
Condition
influenza
NCT02015494_exc_T135
Temporal
within the previous 12 months