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

Phase 3

Completed

• Conditions: Seasonal Influenza
• Interventions: Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent; Biological: Control Quadrivalent influenza virus vaccine

• Registration Number: NCT05431725
• Lead Sponsor: Sinovac Biotech Co., Ltd

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".

Study Timeline

• Study First Submitted: 2022-06-19
• Study First Submitted QC: 2022-06-19
• Study First Posted: 2022-06-24
• Study Start: 2022-07-18
• Primary Completion: 2023-07-19
• Study Completion: 2023-07-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2202

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sinovac-QIV group	Influenza Vaccine (Split Virion), Inactivated, Quadrivalent	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.
Vaxigrip Tetra-QIV group	Control Quadrivalent influenza virus vaccine	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.

Primary Outcome Measures

Name	Time	Method
Seroconversion rates of HI antibody	At day 28 after the last dose	Seroconversion rates of HI antibody at day 28 after the last dose for each of the four antigens.
GMTs of HI antibody	At day 28 after the last dose	GMTs of HI antibody at day 28 after the last dose for each of the four antigens.

Secondary Outcome Measures

Name	Time	Method
Adverse events of special interest (AESI)	Within 28 days after each dose	Adverse events of special interest (AESI) within 28 days after each dose
Seroprotection rates(SCRs) of HI antibody	At day 28 after the last dose	Proportion of subjects with antibody titer ≥1:40 at day 28 after the last dose
Unsolicited AEs	Within 28 days after each dose	Occurrence, intensity, duration, and relationship of unsolicited AEs within 28 days after each dose.
Seroconversion rates (SCRs) of HI antibody	At day 28 after the last dose	Seroconversion rates at day 28 after the last dose.
Solicited local and systemic Adverse Events (AEs)	Within 7 days after each dose	Occurrence, intensity, duration, and relationship of solicited local and systemic Adverse Events (AEs) within 7 days after each dose.
Serious adverse events (SAEs)	Within 28 days after each dose	Occurrence and relationship of serious adverse events (SAEs) within 28 days after each dose

Trial Locations

Locations (11)

Universidad San Sebastián; 🇨🇱 Santiago, Chile

Las Pinas Doctors Hospital; 🇵🇭 Las Pinas, Manila, Philippines

Philippine General Hospital; 🇵🇭 Manila, Philippines

San Juan De Dios Hospital; 🇵🇭 Pasay, Manila, Philippines

Hospital de Puerto Montt; 🇨🇱 Puerto Montt, Chile

CIMER Center/Center for Medical Research on Respiratory Diseases; 🇨🇱 Santiago, Chile

Tropical Disease Foundation Inc; 🇵🇭 Makati City, Manila, Philippines

Hospital Felix Bulnes; 🇨🇱 Santiago, Chile

Clínica Alemana; 🇨🇱 Santiago, Chile

Hospital Clínico UC-Christus; 🇨🇱 Santiago, Chile

Clinica Alemana de Valdivia; 🇨🇱 Valdivia, Chile