A Clinical Trial of A Quadrivalent Influenza Vaccine

Shanghai Institute Of Biological Products

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Trivalent influenza vaccine A; Biological: Quadrivalent influenza vaccine; Biological: Trivalent influenza vaccine B

Study type: Interventional

Funder types: Industry

Identifiers

NCT03744104

JSVCT060

Details and patient eligibility

About

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.

Enrollment: 2,688 patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,688 participants in 3 patient groups

Quadrivalent influenza vaccine

Experimental group

Description:

Quadrivalent influenza vaccine(containing 2 subtypes of B lineage)

Treatment:

Biological: Quadrivalent influenza vaccine

Trivalent influenza vaccine A

Active Comparator group

Description:

Trivalent influenza vaccine (containing B/Victoria lineage)

Treatment:

Biological: Trivalent influenza vaccine A

Trivalent influenza vaccine B

Active Comparator group

Description:

Trivalent influenza vaccine (containing B/Yamagata lineage)

Treatment:

Biological: Trivalent influenza vaccine B