Serious adverse reaction to any vaccination, as respiratory difficulty, angioedema and anaphylaxis; 
Acute or chronic disease, as diabetes, heart disease, systemic arterial hypertension; 
Use of anti-allergic with antigen injections in a maximum timeline of 14 days before the vaccination; 
Use of immunoglobulin in the past 12 months before the study vaccination; 
Use of blood products within 12 months before the vaccination; 
Use of any vaccine type within 30 days before the vaccination of the study; 
Chronic use of any medication, except homeopathy, and trivial ones, as nasal physiologic solution and vitamins; 
Previous immunosuppressive or cytotoxic medication, in the last 6 months. Individuals who have made use of this kind of medication in non-immunosuppressant doses, as nasal corticosteroid for allergic rhinitis of topic corticosteroid for non-complicated dermatitis, for more than 14 days, are allowed to be included in the study. 
Use of any kind of medication under investigation within one year before the vaccination. 
Unstable asthma or which may have required urgent care, hospitalization or intubation within the last 2 years, or which requires use of oral or intravenous corticosteroid. 
Coagulopathies diagnosed by a physician or report of capillary fragility (ex: bruises or bleedings without justifiable cause; 
Convulsions, except the ones caused by fever, before 2 years old; 
Psychiatric disease which difficults the adherence to the protocol, such as psychosis, obsessive-compulsive disorders, bipolar disease under treatment, diseases which require treatment with lithium and suicidal ideas in the last 5 years from the inclusion; 
Active malignant (p.e. any kind of cancer) or treated disease, to which the individual may relapse during the study; 
Asplenia (absence of spleen or its removal); 
Positive HIV in the screening examination of history of any immunosuppressant disease; 
Positive serology for C hepatitis in the screening evaluation; 
Positive Antigen HBs in the screening evaluation; 
Alcoholism (CAGE criteria), used for detection of abusive drinkers or alcoholic, validated in the Brazilian population with sensibility of 88% and specificity of 83%, if two or more answers, among four possible, are afirmative(Mansur and Monteiro, 1983), or according to medical decision; 
Abuse of illicit drugs, according to medical decision; 
Acquired or congenital immunodeficiency; 
Allergy to the vaccine compounds, as egg, neomycin and gelatin.       
    

NCT02196285_exc_T1
Drug
immunoglobulin
NCT02196285_exc_T2
Temporal
in the past 12 months before the study vaccination
NCT02196285_exc_T3
Reference_point
the study vaccination
NCT02196285_exc_T4
Condition
adverse reaction
NCT02196285_exc_T5
Condition
respiratory difficulty
NCT02196285_exc_T6
Procedure
vaccination
NCT02196285_exc_T7
Condition
angioedema
NCT02196285_exc_T8
Condition
anaphylaxis
NCT02196285_exc_T9
Scope
respiratory difficulty, angioedema and anaphylaxis
NCT02196285_exc_T10
Condition
chronic disease
NCT02196285_exc_T11
Condition
diabetes
NCT02196285_exc_T12
Condition
Acute disease
NCT02196285_exc_T13
Condition
heart disease
NCT02196285_exc_T14
Condition
systemic arterial hypertension
NCT02196285_exc_T15
Scope
diabetes, heart disease, systemic arterial hypertension
NCT02196285_exc_T16
Scope
Acute or chronic disease
NCT02196285_exc_T17
Procedure
antigen injections
NCT02196285_exc_T18
Drug
anti-allergic
NCT02196285_exc_T19
Temporal
maximum timeline of 14 days before the vaccination
NCT02196285_exc_T20
Reference_point
the vaccination
NCT02196285_exc_T21
Drug
blood products
NCT02196285_exc_T22
Temporal
within 12 months before the vaccination
NCT02196285_exc_T23
Reference_point
the vaccination
NCT02196285_exc_T24
Drug
any vaccine type
NCT02196285_exc_T25
Temporal
within 30 days before the vaccination of the study
NCT02196285_exc_T26
Reference_point
the vaccination of the study
NCT02196285_exc_T27
Multiplier
Chronic use
NCT02196285_exc_T28
Drug
any medication
NCT02196285_exc_T31
Procedure
homeopathy
NCT02196285_exc_T32
Drug
nasal physiologic solution
NCT02196285_exc_T33
Drug
vitamins
NCT02196285_exc_T35
Drug
trivial ones
NCT02196285_exc_T38
Scope
nasal physiologic solution and vitamins
NCT02196285_exc_T39
Negation
except
NCT02196285_exc_T40
Scope
homeopathy, and trivial ones, as nasal physiologic solution and vitamins
NCT02196285_exc_T41
Drug
immunosuppressive medication
NCT02196285_exc_T42
Drug
cytotoxic medication
NCT02196285_exc_T45
Temporal
in the last 6 months
NCT02196285_exc_T46
Scope
immunosuppressive or cytotoxic medication
NCT02196285_exc_T49
Drug
medication under investigation
NCT02196285_exc_T51
Temporal
within one year before the vaccination
NCT02196285_exc_T52
Reference_point
the vaccination
NCT02196285_exc_T53
Condition
Unstable asthma
NCT02196285_exc_T54
Qualifier
required urgent care
NCT02196285_exc_T55
Procedure
hospitalization
NCT02196285_exc_T56
Procedure
urgent care
NCT02196285_exc_T57
Procedure
intubation
NCT02196285_exc_T58
Qualifier
required hospitalization
NCT02196285_exc_T59
Qualifier
required intubation
NCT02196285_exc_T60
Temporal
within the last 2 years
NCT02196285_exc_T61
Drug
oral corticosteroid
NCT02196285_exc_T62
Drug
intravenous corticosteroid
NCT02196285_exc_T63
Scope
required urgent care, hospitalization or intubation
NCT02196285_exc_T64
Qualifier
requires use of oral corticosteroid
NCT02196285_exc_T65
Qualifier
requires use of intravenous corticosteroid
NCT02196285_exc_T66
Scope
requires use of oral or intravenous corticosteroid
NCT02196285_exc_T67
Scope
required urgent care, hospitalization or intubation within the last 2 years
NCT02196285_exc_T68
Scope
required urgent care, hospitalization or intubation within the last 2 years, or which requires use of oral or intravenous corticosteroid
NCT02196285_exc_T69
Condition
Coagulopathies
NCT02196285_exc_T70
Condition
capillary fragility
NCT02196285_exc_T71
Condition
bruises
NCT02196285_exc_T72
Condition
bleedings
NCT02196285_exc_T73
Qualifier
without justifiable cause
NCT02196285_exc_T75
Scope
bruises or bleedings without justifiable cause
NCT02196285_exc_T76
Condition
Convulsions
NCT02196285_exc_T77
Temporal
before 2 years old
NCT02196285_exc_T78
Qualifier
caused by fever
NCT02196285_exc_T79
Negation
except
NCT02196285_exc_T80
Condition
fever
NCT02196285_exc_T81
Reference_point
2 years old
NCT02196285_exc_T82
Condition
Psychiatric disease
NCT02196285_exc_T83
Qualifier
difficults the adherence to the protocol
NCT02196285_exc_T86
Condition
psychosis
NCT02196285_exc_T87
Condition
obsessive-compulsive disorders
NCT02196285_exc_T88
Condition
bipolar disease
NCT02196285_exc_T89
Qualifier
under treatment
NCT02196285_exc_T90
Procedure
treatment
NCT02196285_exc_T92
Drug
lithium
NCT02196285_exc_T93
Procedure
treatment with lithium
NCT02196285_exc_T94
Condition
suicidal ideas
NCT02196285_exc_T95
Temporal
in the last 5 years from the inclusion
NCT02196285_exc_T96
Reference_point
the inclusion
NCT02196285_exc_T97
Condition
diseases which require treatment with lithium
NCT02196285_exc_T98
Scope
psychosis, obsessive-compulsive disorders, bipolar disease under treatment, diseases which require treatment with lithium and suicidal ideas in the last 5 years from the inclusion
NCT02196285_exc_T99
Condition
malignant disease
NCT02196285_exc_T100
Temporal
Active
NCT02196285_exc_T101
Condition
cancer
NCT02196285_exc_T102
Qualifier
any kind
NCT02196285_exc_T103
Condition
treated disease
NCT02196285_exc_T104
Procedure
treated
NCT02196285_exc_T105
Qualifier
treated
NCT02196285_exc_T106
Qualifier
malignant
NCT02196285_exc_T110
Qualifier
to which the individual may relapse
NCT02196285_exc_T111
Temporal
during the study
NCT02196285_exc_T112
Reference_point
the study
NCT02196285_exc_T113
Scope
Active malignant (p.e. any kind of cancer) or treated disease
NCT02196285_exc_T114
Condition
Asplenia
NCT02196285_exc_T115
Negation
absence of
NCT02196285_exc_T116
Condition
spleen
NCT02196285_exc_T117
Procedure
spleen removal
NCT02196285_exc_T118
Scope
absence of spleen or its removal
NCT02196285_exc_T119
Measurement
HIV
NCT02196285_exc_T120
Value
Positive
NCT02196285_exc_T121
Temporal
in the screening examination
NCT02196285_exc_T122
Reference_point
screening examination
NCT02196285_exc_T123
Condition
immunosuppressant disease
NCT02196285_exc_T125
Measurement
serology for C hepatitis
NCT02196285_exc_T126
Value
Positive
NCT02196285_exc_T127
Temporal
in the screening evaluation
NCT02196285_exc_T128
Reference_point
screening evaluation
NCT02196285_exc_T129
Measurement
Antigen HBs
NCT02196285_exc_T130
Value
Positive
NCT02196285_exc_T131
Temporal
in the screening evaluation
NCT02196285_exc_T132
Reference_point
screening evaluation
NCT02196285_exc_T133
Condition
Alcoholism
NCT02196285_exc_T134
Measurement
CAGE criteria
NCT02196285_exc_T135
Value
Alcoholism
NCT02196285_exc_T137
Condition
Abuse of illicit drugs
NCT02196285_exc_T139
Condition
Acquired immunodeficiency
NCT02196285_exc_T140
Condition
congenital immunodeficiency
NCT02196285_exc_T141
Condition
Allergy to the vaccine compounds
NCT02196285_exc_T142
Drug
vaccine compounds
NCT02196285_exc_T143
Drug
egg
NCT02196285_exc_T144
Drug
neomycin
NCT02196285_exc_T145
Drug
gelatin
NCT02196285_exc_T146
Scope
egg, neomycin and gelatin