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

Phase 3

Completed

• Conditions: Seasonal Influenza

• Registration Number: NCT03853993
• Lead Sponsor: Sinovac Biotech Co., Ltd

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged over 3 years

Detailed 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.

Study Timeline

• Study Start: 2018-01-23
• Primary Completion: 2018-08-17
• Study Completion: 2018-10-08
• Status Verified: 2019-02
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-21
• Last Update Submitted: 2019-02-25
• Study First Posted: 2019-02-26
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2380

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	28 days after the injection	Immunogenicity index, One of the standard to evaluate the experimental vaccine is non-inferior to the control vaccines
The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)≥-10%	28 days after the injection	Immunogenicity index, Another standard to evaluate the experimental vaccine is non-inferior to the control vaccines

Secondary Outcome Measures

Name	Time	Method
The lower limit of 95%CI of the ratio of GMT(experimental group/control group)>1.5 .	28 days after the injection	Immunogenicity index, One of the standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type
The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)>10%	28 days after the injection	Immunogenicity index, Another standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type
The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged 3-59 years≥40%	28 days after the injection	Immunogenicity index
The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged over 60 years≥30%	28 days after the injection	Immunogenicity index
The seroprotective rate (HI antibody titer≥1:40) in the subjects aged 3-59 years ≥70%	28 days after the injection	Immunogenicity index
The seroprotective rate (HI antibody titer≥1:40) in the subjects aged over 60 years ≥60%	28 days after the injection	Immunogenicity index
The geometric mean increase (GMI) in the subjects aged 3-59 years >2.5	28 days after the injection	Immunogenicity index
The geometric mean increase (GMI) in the subjects aged over 60 years >2.0	28 days after the injection	Immunogenicity index
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	28 days after the injection	Immunogenicity index
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	28 days after the injection	Immunogenicity index
The incidence of the solicited local and general adverse reactions on day 0-7	0-7 days after the injection	Safety index, The adverse reactions refers to the adverse events which considered related to the vaccination
The incidence of the unsolicited adverse events on day 0-28	0-28 days after the injection	Safety Index
The incidence of the serious adverse events within 6 months after the injection	Within 6 months after the injection	Safety Index

Trial Locations

Locations (2)

Guanyun Center for Disease Control and Prevention; 🇨🇳 Lianyungang, Jiangsu, China

Pizhou Center for Disease Control and Prevention; 🇨🇳 Pizhou, Jiangsu, China