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

Sinovac Biotech Co., Ltd2,380 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

2,380

Conditions

Seasonal Influenza

Interventions

Quadrivalent influenza vaccineBIOLOGICAL

Received single dose QIV (15µg/0.5ml)

Trivalent influenza vaccine (contains B/Victoria strain)BIOLOGICAL

Received single dose TIV which contains B/Victoria strain (15µg/0.5ml)

Trivalent influenza vaccine (contains B/Yamagata strain)BIOLOGICAL

Received single dose TIV which contains B/Yamagata strain (15µg/0.5ml)

Eligibility

Sex: ALLMin age: 3 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Guanyun Center for Disease Control and Prevention

Lianyungang, Jiangsu, China

Pizhou Center for Disease Control and Prevention

Pizhou, Jiangsu, China

Outcomes

Primary Outcomes

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