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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-23

Study Completion Date

2018-10-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (7.5μg/0.25ml)

NCT03859141

Seasonal Influenza

COMPLETED PHASE3

A Clinical Trial of A Quadrivalent Influenza Vaccine

NCT03744104

Influenza

COMPLETED PHASE3

A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months

NCT06049927

Seasonal Influenza

COMPLETED PHASE3

Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

NCT04363359

Influenza

COMPLETED PHASE2

Safety and Immunogenicity Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged Years 3-60

NCT02806804

Quadrivalent Influenza Virus Vaccine

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Seasonal Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The phase I clinical trial has single arm, and the phase III clinical trial has 3 parallel arms.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group-phase I

Quadrivalent influenza vaccine

Group Type EXPERIMENTAL

Quadrivalent influenza vaccine

Intervention Type BIOLOGICAL

Received single dose QIV (15µg/0.5ml)

Experimental group-phase III

Quadrivalent influenza vaccine

Group Type EXPERIMENTAL

Quadrivalent influenza vaccine

Intervention Type BIOLOGICAL

Received single dose QIV (15µg/0.5ml)

Control group-1-phase III

Trivalent influenza vaccine (contains B/Victoria strain)

Group Type ACTIVE_COMPARATOR

Trivalent influenza vaccine (contains B/Victoria strain)

Intervention Type BIOLOGICAL

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

Control group-2-phase III

Trivalent influenza vaccine (contains B/Yamagata strain)

Group Type ACTIVE_COMPARATOR

Trivalent influenza vaccine (contains B/Yamagata strain)

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quadrivalent influenza vaccine

Received single dose QIV (15µg/0.5ml)

Intervention Type BIOLOGICAL

Trivalent influenza vaccine (contains B/Victoria strain)

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

Intervention Type BIOLOGICAL

Trivalent influenza vaccine (contains B/Yamagata strain)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes