Clinical Trial of Inactivated Influenza Vaccine (0.5ml Formulation)

This is an interventional prevention trial for Influenza focused on measuring Influenza Vaccine, Vaccination, Read More

Inclusion Criteria:

1. Inclusion criteria for the primary vaccination on subjects over 3 years old and subjects 6 months～3 years old

   • Healthy male and female 6 months or over, subject (or their guardians) are able to understand and sign informed consent
   • Healthy person by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product
   • Be able to comply with the requirement of clinical trial protocol
   • Have no history of influenza vaccination within the past 6 months and vaccination with other product within the latest 1 week;
   • Axillary temperature<37.1℃.

2. Inclusion criteria for the boost vaccination on subjects age 6 months～3 years

   • Have no history of vaccination with other preventive product within the latest 1 week;
   • Axillary temperature<37.1℃.

Exclusion Criteria:

1. Exclusion criteria for the primary vaccination on subjects over 3 years old and subjects age 6 months～3 years

   • Serious diseases, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, COPD needing oxygen uptake treatment, acute or progressive liver or kidney disease, CHF, etc.
   • Subjects who are allergic to any component of test vaccine (history of vaccination allergy), especially allergic to eggs
   • History of symptoms or signs in neurological system
   • Known or suspected (high risk of onset) damaged or abnormal immunologic function need receiving immunosuppressant or immunopotentiator treatment; history of receiving immunoglobulin or blood product or plasma extractive outside the gastrointestinal tract within the past 3 months; and HIV infection or relevant diseases
   • Haemorrhage physique or extension of haemorrhage time
   • History of influenza or at least once influenza vaccination within the past 6 months
   • History of receiving other vaccination or injection of immunoglobulin and any test drug within the past 1 week
   • History of any acute disease and infection needing antibiotics or antiviral treatment in whole body within the past 7 days
   • History of fever within the past three days (axillary temperature≥37.1℃)
   • Participating in another clinical trial
   • History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease;
   • Thrombopenia or other coagulopathy that may cause contraindication of intramuscular injection
   • Serious chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, and GBS)
   • Known or suspected diseases at the same time, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of infants or mothers, CVD, serious hypertension, during the treatment of tumor and skin disease
   • Any condition may affect trial assessment in judgment of investigators.

2. Exclusion criteria for the boost vaccination on subjects age 6 months～3 years

   • History of receiving other vaccination or injection of immunoglobulin and any test drug within the past 1 week
   • History of any acute disease and infection needing antibiotics or antiviral treatment in whole body within the past 7 days
   • History of fever within the past three days (axillary temperature≥37.1℃).