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

JSVCT060

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.

2018-10-11

2019-10-08

2019-10-08

Completed

Early phase I

2688

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2688, 'type': 'ACTUAL'}}

2024-01-02