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

NCT05431725 | Completed Phase 3

• 1 other identifier: PRO-QINF-3004
• Study Type: interventional
• Target: 2,202
• Locations: 2 countries
• Sites: 11

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.

Conditions

Seasonal Influenza

Outcome Measures

Primary Outcomes (2)

• Seroconversion rates of HI antibody

  Seroconversion rates of HI antibody at day 28 after the last dose for each of the four antigens.

  At day 28 after the last dose

• GMTs of HI antibody

  GMTs of HI antibody at day 28 after the last dose for each of the four antigens.

  At day 28 after the last dose

Secondary Outcomes (6)

• Seroprotection rates(SCRs) of HI antibody

  At day 28 after the last dose

• Seroconversion rates (SCRs) of HI antibody

  At day 28 after the last dose

• Solicited local and systemic Adverse Events (AEs)

  Within 7 days after each dose

• Unsolicited AEs

  Within 28 days after each dose

• Serious adverse events (SAEs)

  Within 28 days after each dose

Study Arms (2)

Sinovac-QIV group

EXPERIMENTAL

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.

Biological: Influenza Vaccine (Split Virion), Inactivated, Quadrivalent

Vaxigrip Tetra-QIV group

ACTIVE COMPARATOR

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.

Biological: Control Quadrivalent influenza virus vaccine

Interventions

Influenza Vaccine (Split Virion), Inactivated, Quadrivalent 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.

Also known as: Sinovac-QIV

Sinovac-QIV group

Control Quadrivalent influenza virus vaccine 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.

Also known as: Vaxigrip Tetra-QIV

Vaxigrip Tetra-QIV group

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (11)

Hospital de Puerto Montt

Port Montt, Chile

Location

CIMER Center/Center for Medical Research on Respiratory Diseases

Santiago, Chile

Location

Clínica Alemana

Santiago, Chile

Location

Hospital Clínico UC-Christus

Santiago, Chile

Location

Hospital Felix Bulnes

Santiago, Chile

Location

Universidad San Sebastián

Santiago, Chile

Location

Clinica Alemana de Valdivia

Valdivia, Chile

Location

Las Pinas Doctors Hospital

Las Piñas, Manila, Philippines

Location

Tropical Disease Foundation Inc

Makati City, Manila, Philippines

Location

San Juan De Dios Hospital

Pasay, Manila, Philippines

Location

Philippine General Hospital

Manila, Philippines

Location

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Zeng Gang, Senior Medical Director

  Sinovac Biotech Co., Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 24, 2022
• Study Start: July 18, 2022
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

CL (7); PH (4)