Seasonal Influenza
Conditions
Keywords
Influenza Vaccine, Quadrivalent, Trivalent
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.
Interventions
BIOLOGICALQuadrivalent influenza vaccine
Received single dose QIV (15µg/0.5ml)
Received single dose TIV which contains B/Victoria strain (15µg/0.5ml)
Received single dose TIV which contains B/Yamagata strain (15µg/0.5ml)
Sponsors
Sinovac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
The phase I clinical trial has single arm, and the phase III clinical trial has 3 parallel arms.
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 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 |
Countries
China
Outcome results
None listed