A Clinical Trial of A Quadrivalent Influenza Vaccine

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744104
• Other study ID #: JSVCT060
• Status: Completed
• Phase: Phase 3
• Start date: October 11, 2018
• Est. completion date: October 8, 2019

Study information

• Verified date: December 2023
• Source: Shanghai Institute Of Biological Products
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2688
• Est. completion date: October 8, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Quadrivalent influenza vaccine
0.5 mL, intramuscular, one dose
• Trivalent influenza vaccine A
0.5 mL, intramuscular, one dose
• Trivalent influenza vaccine B
0.5 mL, intramuscular, one dose

Locations

Country	Name	City	State
China	Suining County Center for Disease Control and Prevention	Xuzhou	Jiangsu
China	Xinyi County Center for Disease Control and Prevention	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Institute Of Biological Products

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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