A Clinical Trial of A Quadrivalent Influenza Vaccine

Immunogenicity and Safety of a Quadrivalent Influenza Vaccine in Participants Aged Above 3 Years

The aim of this study is to assess the immunogenicity and safety of a quadrivalent influenza vaccine compared with a trivalent influenza vaccine in participants aged above 3 years.

Inclusion Criteria:

• Over the age of three years,healthy population
• Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required
• To comply with the requirements of clinical trial program
• Temperature≤37.0℃ on day of enrollment

Exclusion Criteria:

• A history of influenza virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes in last three months
• Any prior administration of influenza vaccine in last six months
• Allergy to any component in the vaccine, especially for egg allergy
• Allergy history of any previous vaccination or drug
• Acute episodes of chronic illness or acute illness on the day of vaccination
• Received a live vaccine within fourteen days prior to receiving the vaccine, or received a subunit or inactivated vaccine within seven days
• Congenital or acquired immune deficiencies, or treatment with immunosuppressive agents, such as long-term treatment with systemic corticosteroids
• Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome)
• Asthma, required urgent treatment in last two years
• The blood products were received prior to the acceptance of the vaccine
• Known or suspected of respiratory disease, acute infection or chronic disease active period, HIV infection, cardiovascular disease, severe hypertension, malignant tumor during treatment, skin diseases
• History of epilepsy, convulsions, or a family history of psychosis
• Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities), or obvious bruising or coagulopathy
• Plan to move or leave the area for an extended period of time before the end of the study
• Under anti-tb treatment
• Any prior administration of other research medicine/vaccine in last one month
• Women are pregnant or in the near future planned pregnancy or pregnancy test positive