Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)
- Conditions
- Seasonal Influenza
- Interventions
- Biological: Quadrivalent influenza vaccineBiological: Trivalent influenza vaccine (contains B/Victoria strain)Biological: Trivalent influenza vaccine (contains B/Yamagata strain)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2380
- 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;
- 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
- Arm && Interventions
Group Intervention Description Experimental group-phase I Quadrivalent influenza vaccine Quadrivalent influenza vaccine Experimental group-phase III Quadrivalent influenza vaccine Quadrivalent influenza vaccine Control group-1-phase III Trivalent influenza vaccine (contains B/Victoria strain) Trivalent influenza vaccine (contains B/Victoria strain) Control group-2-phase III Trivalent influenza vaccine (contains B/Yamagata strain) Trivalent influenza vaccine (contains B/Yamagata strain)
- 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)
Pizhou Center for Disease Control and Prevention
🇨🇳Pizhou, Jiangsu, China
Guanyun Center for Disease Control and Prevention
🇨🇳Lianyungang, Jiangsu, China