Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)

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 Over 3 Years.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853993
• Other study ID #: PRO-QINF-3001
• Status: Completed
• Phase: Phase 3
• Start date: January 23, 2018
• Est. completion date: October 8, 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 subjects aged over 3 years

Description:

This study is a phase I& III clinical trial. Phase I is open-labelled, and phase III is randomized, double-blind, active-controlled. The purpose of this study is to evaluate the safety and immunogenicity of the quadrivalent influenza vaccine (QIV) (experimental vaccine) manufactured by Sinovac Biotech Co., Ltd in subjects aged over 3 years. In phase I, 60 volunteers received single dose QIV (15µg/0.5ml). In phase III, 2320 volunteers were assigned to receive single dose QIV (15µg/0.5ml) or two commercial trivalent influenza vaccines (TIVs) (15µg/0.5ml) in a ratio of 2:1:1. The commercial TIVs were also manufactured by Sinovac Biotech Co., Ltd.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2380
• Est. completion date: October 8, 2018
• Est. primary completion date: August 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• Healthy volunteers aged =3 years;

• Proven legal identity;

• Participants or (and) guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;

Exclusion Criteria:

• Prior vaccination with influenza vaccine of the current year;

• History of influenza within 6 months prior to study entry;

• Axillary temperature > 37.0 °C;

• History of allergy to any vaccine, or any ingredient of the experimental vaccine, especially eggs, egg albumin, etc.;

• Serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc.;

• Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;

• Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry;

• History of asthma, thyroidectomy, angioedema, diabetes or malignancy;

• No spleen, or functional no spleen, or splenectomy.

Related Conditions & MeSH terms

• Influenza, Human
• Seasonal Influenza

Intervention

Biological:
• Quadrivalent influenza vaccine
Received single dose QIV (15µg/0.5ml)
• Trivalent influenza vaccine (contains B/Victoria strain)
Received single dose TIV which contains B/Victoria strain (15µg/0.5ml)
• Trivalent influenza vaccine (contains B/Yamagata strain)
Received single dose TIV which contains B/Yamagata strain (15µg/0.5ml)

Locations

Country	Name	City	State
China	Guanyun Center for Disease Control and Prevention	Lianyungang	Jiangsu
China	Pizhou Center for Disease Control and Prevention	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 the ratio of geometric mean titer of hemagglutination inhibition (HI) antibody titer (experimental group/control group)=2/3.	Immunogenicity index, One of the standard to evaluate the experimental vaccine is non-inferior to the control vaccines	28 days after the injection
Primary	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 non-inferior to the control vaccines	28 days after the injection
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 the injection
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 the injection
Secondary	The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged 3-59 years=40%	Immunogenicity index	28 days after the injection
Secondary	The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged over 60 years=30%	Immunogenicity index	28 days after the injection
Secondary	The seroprotective rate (HI antibody titer=1:40) in the subjects aged 3-59 years =70%	Immunogenicity index	28 days after the injection
Secondary	The seroprotective rate (HI antibody titer=1:40) in the subjects aged over 60 years =60%	Immunogenicity index	28 days after the injection
Secondary	The geometric mean increase (GMI) in the subjects aged 3-59 years >2.5	Immunogenicity index	28 days after the injection
Secondary	The geometric mean increase (GMI) in the subjects aged over 60 years >2.0	Immunogenicity index	28 days after the injection
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 the injection
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 the injection
Secondary	The incidence of the solicited local and general adverse reactions on day 0-7	Safety index, The adverse reactions refers to the adverse events which considered related to the vaccination	0-7 days after the injection
Secondary	The incidence of the unsolicited adverse events on day 0-28	Safety Index	0-28 days after the injection
Secondary	The incidence of the serious adverse events within 6 months after the injection	Safety Index	Within 6 months after the injection