Status:
COMPLETED
Immunogenicity and Safety Study of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Seasonal Influenza
Eligibility:
All Genders
3+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of Influenza vaccine (Split virion), Inactivated, Quadrivalent developed by Sinovac Biotech Co., Ltd. (Sinovac-QIV) as compared t...
Detailed Description
This study is a phase Ⅲ, double-blind, randomized and active-controlled clinical trial to evaluate the safety and immunogenicity of Influenza vaccine (Split virion), Inactivated, Quadrivalent develope...
Eligibility Criteria
Inclusion
- Volunteers age 3 years and older, in good health or medically stable;
- Written informed consent obtained from subjects or/and legal guardian;
- No receipt of influenza vaccines within 6 months or plans to receive any influenza vaccines during the study;
- Female subjects of non-child bearing may be enrolled in the study. Non-child bearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or premenarche or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening without an alternative medical cause);
- Female subjects of child bearing potential may be enrolled in the study, if the subject
- Has a negative pregnancy test on the day of the first dose (day 0);
- Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose and until at least 28 days after vaccination.
Exclusion
- History of seasonal influenza within 6 months prior to the study entry;
- Axillary temperature ≥37.3℃;
- History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine;
- History of allergy to any vaccine, or any ingredient of the experimental vaccine;
- Serious adverse reaction(s) to the vaccine, such as urticaria, dyspnea or angioneurotic edem etc.;
- History of serious neurological disorder (such as epilepsy, convulsions etc.) or a mental illness;
- Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry;
- Significant chronic illnesses that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion (may include, but are not limited to cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, liver or kidney disorders, HIV infection or malignant tumor;
- Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
- Absence of spleen, functional absence of spleen, and absence or removal of spleen under any circumstances;
- Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities), or obvious bruising or coagulation disorders;
- Alcoholism or history of drug abuse；
- Acute disease or acute stage of chronic disease within 7 days prior to study entry;
- Received blood products within 3 months prior to study entry;
- Received any live attenuated vaccine within 14 days prior to study entry or any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- Pregnant women or lactating women;
- Subjects participate other clinical trials (licensed or unlicensed vaccines, drugs, organisms, devices, blood products or drugs) during the study period;
- Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2023
Estimated Enrollment :
2202 Patients enrolled
Trial Details
Trial ID
NCT05431725
Start Date
July 18 2022
End Date
July 19 2023
Last Update
May 28 2024
Active Locations (11)
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1
Hospital de Puerto Montt
Port Montt, Chile
2
CIMER Center/Center for Medical Research on Respiratory Diseases
Santiago, Chile
3
Clínica Alemana
Santiago, Chile
4
Hospital Clínico UC-Christus
Santiago, Chile