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

Seasonal Influenza Clinical Trial

Official title:

A Phase Ⅲ, Randomized, Double-blind and Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Individuals Aged 3 Years and Older

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431725
• Other study ID #: PRO-QINF-3004
• Status: Recruiting
• Phase: Phase 3
• Start date: July 18, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: April 2023
• Source: Sinovac Biotech Co., Ltd
• Contact: Yang Wanqi, Medical Manager
• Phone: 86-13051512756
• Email: yangwq[@]sinovac.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2161
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human
• Seasonal Influenza

Intervention

Biological:
• 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.
• 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.

Locations

Country	Name	City	State
Chile	Hospital de Puerto Montt	Puerto 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
Philippines	Las Pinas Doctors Hospital	Las Pinas	Manila
Philippines	Tropical Disease Foundation Inc	Makati City	Manila
Philippines	Philippine General Hospital	Manila
Philippines	San Juan De Dios Hospital	Pasay	Manila

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Countries where clinical trial is conducted

Chile,  Philippines, 

Outcome

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