A Phase I Clinical Trial With Whole Virus Inactivated Influenza H5N1 Vaccine in Healthy Adolescents and Adults

Inclusion Criteria: * Healthy subjects aged from 12 to 60 years old of normal intelligence; * The subjects' guardians are able to understand and sign the informed consent; * Subjects established as healthy after medical history questioning, physical examination and clinical decision; * Subjects who can comply with the requirements of the clinical trial protocol; * Subjects who have never received influenza H5N1 vaccine and other preventive products; * Subjects with temperature ≤37°C on axillary setting. Exclusion Criteria: Exclusion Criteria for the first dose: * Women in pregnancy / lactation or plan to be pregnant during the study; * The subject has a history of allergy or is allergic with any Ingredient of vaccine, such as egg, ovalbumin; * Had serious adverse reactions in previous vaccination, such as allergies, hives, difficult breath, angioneurotic edema or abdominal pain; * Autoimmune diseases or immune deficiency; * Had asthma, over the past two years, the condition is unstable in need of emergency treatment, hospitalization and oral or intravenous corticosteroids; * Diabete (type I or type II) not including gestational diabete; * Thyroidectomy history, or treatment because of thyroid diseases in the past 12 months; * Over the past 3 years, severe angioneurotic edema, or need treatment in the past 2 years; * Severe hypertension and blood pressure is still more than 150/100 mmHg after drug maintenance therapy; * coagulation abnormalities diagnosed by doctor (such as lack of coagulation factors, coagulation disorder diseases, platelet abnormality) or coagulation disorder; * Malignancy, active or treated tumor without explicitly been cured, or the possibility of a recurrence during the study period; * Epilepsy not including alcohol epilepsy of stop drinking in the first 3 years or the simplicity not requiring treatment in the past 3 years; * Asplenia, functional asplenia, and any circumstances leading to asplenia or splenectomy; * Guillain-Barre syndrome; * Had immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray to treat allergic rhinitis and corticosteroid treatment of the acute uncomplicated dermatitis) within the past six months; * Received immune globulin in three months before study; * Received other experimental drugs in 30 days before study; * Received live attenuated vaccine in 30 days before study; * Receiving subunit or inactivated vaccines in 14days before study, such as pneumococcal vaccine or allergy treatment; * In prevention or treatment of the anti-TB (antituberculosis) now; * Had fever (axillary temperature ≥ 38.0℃) 3 days before vaccination or had any acute illness in the past five days requiring systemic antibiotics or antiviral therapy); * The subject is unable to comply with the study requirements because of psychology, or had mental illness or dual-stage affective psychosis not well controlled within the past two years or had psychology in medication and suicidal tendency in the past five years; * According to the researcher, contrary to the study protocol or effect signed informed consent due to a variety of medical, psychological, social conditions, occupational factors or other conditions. Exclusion Criteria for the second dose: * Had any vaccination-related Grade 3 or more adverse reactions in 72 hours after first vaccination; * Any situation meets the exclusion criteria stated in the exclusion criteria for first dose; * Had serious adverse reactions caused by the study vaccination. * Acute infection; * Any condition the investigator believed may affect the evaluation of the vaccine.