Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (7.5μg/0.25ml)

Seasonal Influenza Clinical Trial

Official title:

Open Phase I and Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6-35 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03859141
• Other study ID #: PRO-QINF-3002
• Status: Completed
• Phase: Phase 3
• Start date: February 6, 2018
• Est. completion date: November 2, 2018

Study information

• Verified date: February 2019
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy children aged 6-35 months.

Description:

The study includes open-labelled phase I and randomized, double-blind, controlled phase III clinical trial. In the phase I, 20 healthy Chinese children aged 6-35 months were administered with two doses of QIV (7.5μg/0.25ml). In the phase Ⅲ clinical trial, 2320 children were assigned to QIV group, TIV (B/Victoria) group and TIV (B/Yamagata) group in a 2:1:1 ratio. All vaccines were manufactured by Sinovac Biotech Co., Ltd.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2340
• Est. completion date: November 2, 2018
• Est. primary completion date: April 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 35 Months

Eligibility

Inclusion Criteria:

• Healthy volunteer between 6 - 35 months old; Term birth; Birth weight >2500g;

• Proven legal identity;

• Written consent of the guardian(s) of the volunteer;

Exclusion Criteria:

• Received seasonal influenza vaccine in the current year;

• Suffering from seasonal influenza in the past 6 moths;

• Axillaty temperature > 37.0 °C;

• History of allergy to any vaccine or vaccine ingredient;

• History of serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;

• Autoimmune disease or immunodeficiency;

• Congenital malformation, developmental disorders;

• Severe malnutrition;

• Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;

• History of epilepsy (except febrile seizures occurred < 2 years of age or pure epilepsy occurred within the past 3 years that does not need treatment)

• Chronic diseases (e.g., viral hepatitis, tuberculosis, diabetes, blood diseases, or neurological disorders)

• Acute disease or acute stage of chronic disease;

• Receipt of any of the following products:

1. Any subunit vaccine or inactivated vaccine (e.g., pneumococcal vaccine) or treatment of allergy within 14 days prior to study entry;

2. Any live attenuated vaccine within 30 days prior to study entry;

3. Any other investigational medicine(s) or vaccine within 30 days prior to study entry;

4. Blood product within 3 months prior to study entry;

5. Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry;

• Participate or will participate in other clinical trial(s) during this study;

• Based on the judgment of investigator(s) or the Ethic Committee, there was any condition indicating that the subject should be excluded;

Related Conditions & MeSH terms

• Influenza, Human
• Seasonal Influenza

Intervention

Biological:
• Quadrivalent influenza vaccine
One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5µg antigen.
• Quadrivalent influenza vaccine
One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5µg antigen.
• Trivalent influenza vaccine (contains B/Victoria strain)
One dose of trivalent influenza vaccine (contains B/Victoria strain): 0.25 ml per dose containing 7.5µg antigen.
• Trivalent influenza vaccine (contains B/Yamagata strain)
One dose of trivalent influenza vaccine (contains B/Yamagata strain): 0.25 ml per dose containing 7.5µg antigen.

Locations

Country	Name	City	State
China	Guanyun Center for Disease Prevention and Control	Lianyungang	Jiangsu
China	Pizhou Center for Disease Prevention and Control	Pizhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The lower limit of 95% confidence intervals (95%CI) of geometric mean titer (GMT) ratio (experimental group/control group) of hemagglutination inhibition (HI) antibody titer=2/3.	Immunogenicity index, One of the standard to evaluate the experimental vaccine is non-inferior to the control vaccines.	28 days after two doses immunization
Primary	The lower limit of 95% CI of the seroconversion rate difference (experimental group-control group)=-10%.	Immunogenicity index, Another standard to evaluate the experimental vaccine is non-inferior to the control vaccines.	28 days after two doses immunization
Secondary	The lower limit of 95%CI of the ratio of GMT (experimental group/control group) >1.5.	Immunogenicity index, One of the standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type.	28 days after two doses immunization
Secondary	The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)>10%	Immunogenicity index, Another standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type.	28 days after two doses immunization
Secondary	The lower limit of 95% CI of seroconversion rate for each HI antibody after two doses immunization=40%.	Immunogenicity index	28 days after two doses immunization
Secondary	The seroprotective rate (HI antibody titer=1:40) of each HI antibody after two doses immunization=70%.	Immunogenicity index	28 days after two doses immunization
Secondary	The geometric mean increase (GMI) of each HI antibody after two doses immunization >2.5.	Immunogenicity index	28 days after two doses immunization
Secondary	The lower limit of 95%CI of the ratio of GMT(experimental group/control group)=2/3, in the subjects whose pre-immune HI antibody titer<1:40	Immunogenicity index	28 days after two doses immunization
Secondary	The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)=-10%, in the subjects whose pre-immune HI antibody titer<1:40.	Immunogenicity index	28 days after two doses immunization
Secondary	The incidence of the solicited local and general adverse reactions 0-7 days after each immunization.	Safety index, The adverse reactions refers to the adverse events which were considered related to the vaccination.	0-7 days
Secondary	The incidence of the unsolicited adverse events 0-28 days after each immunization	Safety Index	0-28 days after each dose immunization
Secondary	The incidence of the serious adverse events within 7 months after the first immunization.	Safety Index	Within 7 months after the first dose immunization