| Eligibility |
Inclusion Criteria:
- (1)The age at the time of joining the group is 6-35 months old, and can provide legal
identification.
- (2)The legal guardian of the subject voluntarily agreed to the child's participation
in the study and signed the informed consent form.
- (3)The legal guardian of the subject has the ability to understand the research
procedures and to participate in the follow-up of all plans.
- (4)On the day of joining the group, the armpit temperature was less than 37.3 ?.
Exclusion Criteria:
- (1)Before joining the group, they have been vaccinated against influenza in this
epidemic season or have plans to receive influenza vaccination during the study
period.
- (2)Suffered from influenza disease in the past 3 months (confirmed by clinical,
serological or microbiological methods)
- (3)Babies (6-11 months old) are born with a gestational age of < 37 weeks or = 42
weeks.
- (4)Babies (6-11 months old) weigh less than 2.5kg or > 4.0kg at birth and are not
suitable to participate in this study.
- (5)Babies (6-11 months old) are born during abnormal labor (dystocia, instrumental
delivery, excluding caesarean section) or have a history of asphyxia or neurological
damage
- (6)Previous history of severe allergy to any vaccine / drug or to any component of the
test vaccine (including ovalbumin, etc.), such as anaphylactic shock, anaphylactic
laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic
necrotic reaction (Arthus reaction), severe urticaria, etc.
- (7)Have a history of severe allergy to eggs or egg proteins, such as angioneurotic
edema, dyspnea, chest tightness, or repeated vomiting due to eating eggs, or even use
epinephrine or other emergency medical treatment, especially those who develop
symptoms within a short period of time (minutes to hours) after eating.
- (8)Acute disease or acute attack of chronic disease occurred within 3 days before
vaccination.
- (9)Before entering the group, the interval between other live vaccines was less than 7
days, and the interval between live attenuated vaccines was less than 14 days.
- (10)Use antipyretic analgesic or antiallergic drugs within 3 days before entering the
group.
- (11)Have used other research or unregistered products (drugs or vaccines) within 1
month before joining the group, or plan to participate in other clinical studies after
joining the group.
- (12)Long-term use of immunosuppressants or other immunomodulatory drugs within the
first 3 months (defined as continuous use for more than 14 days), such as
glucocorticoid dose = 0.5mg/kg/ days (inhaled and topical glucocorticoids are not
restricted)
- (13)Received blood or blood-related products within 6 months before joining the group
(hepatitis B immunoglobulin acceptable).
- (14)Has been diagnosed with congenital or acquired immunodeficiency disease.
- (15)Suffering from serious diseases or congenital malformations that may interfere
with the conduct or completion of research (including, but not limited to, respiratory
diseases such as asthma or chronic bronchitis, Down syndrome, thalassemia, heart
disease, nephropathy, autoimmune diseases, Guillain-Barre syndrome, severe
developmental disorders, severe eczema, etc.)
- (16)Has been diagnosed with systemic diseases that may interfere with the conduct or
completion of research, such as tuberculosis, viral hepatitis and / or human
immunodeficiency virus HIV infection.
- (17)Have a history of convulsions, epilepsy, encephalopathy and mental illness or
family history.
- (18)There are contraindications for intramuscular injection, such as having been
diagnosed with thrombocytopenia, any coagulation disorder or receiving anticoagulant
treatment.
- (19)No spleen, functional no spleen, and no spleen or splenectomy caused by any
condition.
- (20)Plan to move out of Hong Kong before the end of the study or for a long period of
time during the visit to the project study.
- (21)The researchers believe that the subjects have any situation that may interfere
with the evaluation of the purpose of the study.
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