Last updated 2 years ago
Phase Ⅲ, Clinical Trial to Compare an Inactivated Quadrivalent Influenza Vaccine and a Licensed Vaccine in Chile
1600 patients around the world
Available in Chile
The study is designed to evaluate the immunogenicity of the quadrivalent inactivated-virus
influenza vaccine developed by Sinovac Biotech Co., Ltd against Vaxigrip Tetra™. The
population included in the study is healthy subjects 3 years and older, being 800 individuals
10 years old or less and 800 over 18 years, randomized 1:1 to experimental vaccine or
Vaxigrip Tetra™. Volunteers 8 years old or less, without history of previous influenza
infection will receive 2 doses of vaccine, al other individuals will receipt 1 dose of
vaccine. Immunogenicity will be assessed one month after the last dose of vaccine, humoral
responses will be determined for all patients meanwhile ome subgroup of patients will have a
determination of cellular immunity also. Subjects will be follow up for one month, adverse
events will be assessed during this time.
Pontificia Universidad Catolica de Chile
4Research sites
1600Patients around the world
Requirements for the patient
From 3 Years
All Gender
Medical requirements
- 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-childbearing may be enrolled in the study. Nonchildbearing 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 childbearing potential may be enrolled in the study, if the subject:
- 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 edema, etc.;History of serious neurological disorder (such as epilepsy, convulsions, etc.) , or 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 abuseAcute 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.
Sites
Hospital Félix Bulnes
Recruiting
Centro de Investigaciones Médicas Respiratorias (CIMER) - Chile
Recruiting
Hospital Puerto Montt
Recruiting
Clínica Alemana
Recruiting
StudyTetraFluVac
SponsorPontificia Universidad Catolica de Chile
Study typeInterventional
Requirements
From 3 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05494047
