Immunogenicity and Safety Study of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent

NCT ID: NCT05431725

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2023-07-19

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 to a licensed comparator in Chile and Philippines, Vaxigrip Tetra™ (Vaxigrip Tetra-QIV) in individuals aged 3 years and older.

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 developed by Sinovac Biotech Co., Ltd. (Sinovac-QIV) as compared to a licensed comparator in Chile, Vaxigrip Tetra™ (Vaxigrip Tetra-QIV) in individuals aged 3 years and older. Subjects will be randomized 1:1 to received either Sinovac-QIV or Vaxigrip Tetra-QIV. Vaccine-primed subjects will receive one 0.5ml dose of Sinovac-QIV or Vaxigrip Tetra-QIV on day 0. Vaccine-unprimed subjects will receive two 0.5ml doses of Sinovac-QIV or Vaxigrip Tetra-QIV and day 0 and day 28, respectively. Subjects who are 3-8 years of age had prior receipt of ≥2 doses of influenza vaccine at least 4 weeks apart or who are ≥9 years old are considered "vaccine-prime". Subjects who are 3-8 years of age had prior receipt of <2 dose of influenza vaccine are considered "vaccine-unprimed".

Conditions

Seasonal Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Sinovac-QIV group

800 subjects aged 3 years and older will receive one dose of Sinovac-QIV for vaccine-primed subjects or two doses of Sinovac-QIV for vaccine-unprimed subjects.

Group Type: EXPERIMENTAL

Influenza Vaccine (Split Virion), Inactivated, Quadrivalent

Intervention Type: BIOLOGICAL

The influenza vaccines (Split Virion), inactivated, quadrivalent are developed by Sinovac Biotech Co., Ltd.15 μg hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride,disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is intramuscular injection into deltoid region.

Vaxigrip Tetra-QIV group

800 subjects aged 3 years and older will receive one dose of Vaxigrip Tetra-QIV for vaccine-primed subjects or two doses of Vaxigrip Tetra-QIV for vaccine-unprimed subjects.

Group Type: ACTIVE_COMPARATOR

Control Quadrivalent influenza virus vaccine

Intervention Type: BIOLOGICAL

The Control Quadrivalent influenza virus vaccines are manufactured by Sanofi and are purchased by Pontifical Catholic University of Chile.15μg HA of each of the four influenza strains in 0.5 mL of solution per injection.The routine of administration is intramuscular injection into deltoid region.

Interventions

Influenza Vaccine (Split Virion), Inactivated, Quadrivalent

The influenza vaccines (Split Virion), inactivated, quadrivalent are developed by Sinovac Biotech Co., Ltd.15 μg hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride,disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.The routine of administration is intramuscular injection into deltoid region.

Intervention Type: BIOLOGICAL

Control Quadrivalent influenza virus vaccine

The Control Quadrivalent influenza virus vaccines are manufactured by Sanofi and are purchased by Pontifical Catholic University of Chile.15μg HA of each of the four influenza strains in 0.5 mL of solution per injection.The routine of administration is intramuscular injection into deltoid region.

Intervention Type: BIOLOGICAL

Other Intervention Names

Sinovac-QIV; Vaxigrip Tetra-QIV

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zeng Gang, Senior Medical Director

Role: STUDY_DIRECTOR

Sinovac Biotech Co., Ltd

Locations

Hospital de Puerto Montt

Port Montt, , Chile

CIMER Center/Center for Medical Research on Respiratory Diseases

Santiago, , Chile

Clínica Alemana

Santiago, , Chile

Hospital Clínico UC-Christus

Santiago, , Chile

Hospital Felix Bulnes

Santiago, , Chile

Universidad San Sebastián

Santiago, , Chile

Clinica Alemana de Valdivia

Valdivia, , Chile

Las Pinas Doctors Hospital

Las Piñas, Manila, Philippines

Tropical Disease Foundation Inc

Makati City, Manila, Philippines

San Juan De Dios Hospital

Pasay, Manila, Philippines

Philippine General Hospital

Manila, , Philippines

Countries

Chile; Philippines

Other Identifiers

PRO-QINF-3004

Identifier Type: -

Identifier Source: org_study_id