A Clinical Trial of A Quadrivalent Influenza Vaccine

Study Overview
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Brief Summary
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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.

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

Conditions
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Influenza

Intervention / Treatment
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* Biological: Quadrivalent influenza vaccine
* Biological: Trivalent influenza vaccine A
* Biological: Trivalent influenza vaccine B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadrivalent influenza vaccine<br>Quadrivalent influenza vaccine(containing 2 subtypes of B lineage) | Biological: Quadrivalent influenza vaccine<br>* 0.5 mL, intramuscular, one dose<br>|
| Active Comparator: Trivalent influenza vaccine A<br>Trivalent influenza vaccine (containing B/Victoria lineage) | Biological: Trivalent influenza vaccine A<br>* 0.5 mL, intramuscular, one dose<br>|
| Active Comparator: Trivalent influenza vaccine B<br>Trivalent influenza vaccine (containing B/Yamagata lineage) | Biological: Trivalent influenza vaccine B<br>* 0.5 mL, intramuscular, one dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that presented seroconversion post injection | Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more. Participants will be collected blood post first study injection, when blood samples will be taken for HI testing | 30 days after inoculation | 
| Geometric mean of Hemagglutination-inhibition titre post first study injection | Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants post first study injection. Participants will be collected blood post first study injection, when blood samples will be taken for HI testing. | 30 days after inoculation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that presented seroprotection post injection | Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40. Participants will be collected blood post first study injection, when blood samples will be taken for HI testing | 30 days after inoculation | 
| Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs) | For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval | Continuous observation for 30 days after two inoculations |