Clinical trial NCT03853993: Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Influenza
Keywords: Influenza Vaccine
Quadrivalent
Trivalent
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-02-26
Enrollment: 2380
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The phase I clinical trial has single arm, and the phase III clinical trial has 3 parallel arms.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 28 days after the injection
measure: The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)≥-10%
timeFrame: 28 days after the injection
Secondary outcomes:
measure: The lower limit of 95%CI of the ratio of GMT(experimental group/control group)>1.5 .
timeFrame: 28 days after the injection
measure: The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)>10%
timeFrame: 28 days after the injection
measure: The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged 3-59 years≥40%
timeFrame: 28 days after the injection
measure: The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged over 60 years≥30%
timeFrame: 28 days after the injection
measure: The seroprotective rate (HI antibody titer≥1:40) in the subjects aged 3-59 years ≥70%
timeFrame: 28 days after the injection
measure: The seroprotective rate (HI antibody titer≥1:40) in the subjects aged over 60 years ≥60%
timeFrame: 28 days after the injection
measure: The geometric mean increase (GMI) in the subjects aged 3-59 years >2.5
timeFrame: 28 days after the injection
measure: The geometric mean increase (GMI) in the subjects aged over 60 years >2.0
timeFrame: 28 days after the injection
measure: 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
timeFrame: 28 days after the injection
measure: 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
timeFrame: 28 days after the injection
measure: The incidence of the solicited local and general adverse reactions on day 0-7
timeFrame: 0-7 days after the injection
measure: The incidence of the unsolicited adverse events on day 0-28
timeFrame: 0-28 days after the injection
measure: The incidence of the serious adverse events within 6 months after the injection
timeFrame: Within 6 months after the injection
Other outcomes:
Locations:
city: Lianyungang
country: China
facility: Guanyun Center for Disease Control and Prevention
state: Jiangsu
city: Pizhou
country: China
facility: Pizhou Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu Province Center for Disease Control and Prevention
name: Yuemei Hu, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chu K, Xu K, Tang R, Tian X, Hu J, Yang T, Li C, Hu Y, Zeng G. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: A randomized, double-blind, controlled phase III study in healthy population aged >/=3 years. Vaccine. 2020 Aug 18;38(37):5940-5946. doi: 10.1016/j.vaccine.2020.06.071. Epub 2020 Jul 27.