Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated

NCT05512494 | Completed Phase 4

• 1 other identifier: PRO-QINF-4003
• Study Type: interventional
• Target: 1,260
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind phase Ⅳ clinical trial of quadrivalent influenza vaccine (Split Virion), inactivated manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the lot-to-lot consistency, immunogenicity and safety of quadrivalent influenza vaccine (Split Virion), inactivated in health subjects aged 9-59 years old.

Conditions

Seasonal Influenza

Outcome Measures

Primary Outcomes (1)

• Immunogenicity index of GMT

  GMT of HI antibodies of each influenza strain at 28 days after vaccination.

  28 days after vaccination

Secondary Outcomes (7)

• Immunogenicity index of seroconversion rate

  28 days after vaccination

• Immunogenicity index of protection rate

  28 days after vaccination

• Immunogenicity index of GMI

  28 days after vaccination

• Safety index of the incidence of adverse reactions

  From 0 to 28 days after vaccination.

• Safety index -The incidence of adverse reactions

  From 0 to 7 days after vaccination.

Study Arms (3)

Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 1

EXPERIMENTAL

420 participants including 120 subjects aged 9-17 years and 300 subjects aged 18-59 years will receive one dose of quadrivalent influenza vaccine of commercial scale production lot 1.

Biological: Quadrivalent Influenza Vaccine (Split Virion), inactivated

Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 2

EXPERIMENTAL

420 participants including 120 subjects aged 9-17 years and 300 subjects aged 18-59 years will receive one dose of quadrivalent influenza vaccine of commercial scale production lot 2.

Biological: Quadrivalent Influenza Vaccine (Split Virion), inactivated

Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 3

EXPERIMENTAL

420 participants including 120 subjects aged 9-17 years and 300 subjects aged 18-59 years will receive one dose of quadrivalent influenza vaccine of commercial scale production lot 3.

Biological: Quadrivalent Influenza Vaccine (Split Virion), inactivated

Interventions

Quadrivalent Influenza Vaccine (Split Virion), inactivated BIOLOGICAL

The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd. The four influenza strains（including 4 antigens H1N1, H3N2, BV and BY, 15μg for each) in 0.5 mL of sodium chloride,disodium hydrogen phosphate,sodium dihydrogen phosphate water for per injection.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0.

Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 1; Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 2; Quadrivalent Influenza Vaccine (Split Virion), inactivated Lot 3

Eligibility Criteria

• Age: 9 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy subjects aged 9-59 years;
• The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 9-17 years, both subjects and guardians need to sign the informed consent form).
• Proven legal identity.

You may not qualify if:

• Received seasonal influenza vaccine for 2022-2023 influenza season, or had an influenza vaccine schedule during the study;
• Suffering from seasonal influenza in the past 6 moths;
• Women of childbearing age (menarche to premenopause) are pregnant(including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month;
• Patients with fever on the day of vaccination,underarm body temperature\>37.2 ℃;
• History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
• Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
• Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
• Autoimmune disease or immune deficiency/immunosuppression;
• Thyroid disease or history of thyroidectomy,absence of spleen, functional functional asplenia,and absence of spleen or splenectomy as a result of any condition;
• Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
• Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
• A long history of alcohol or drug abuse;
• Onset of various acute or chronic diseases within 7 days prior to the study;
• Receipt of blood products within in the past 3 months;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Yuping Dong Autonomous County Center for Disease Control and Prevention

Zhumadian, Guizhou, 554099, China

Location

Related Publications (1)

• Gao Y, Yang X, Li X, Chen H, Li Y, Tan X, Yu D, Feng T, Zhou S, Lei S, Zhao C, Wang J, Guan Q. Lot-to-lot consistency, immunogenicity and safety of a quadrivalent split virion inactivated influenza vaccine in healthy population aged 9-59 years: A randomized, double-blind, controlled, phase IV clinical trial. Vaccine. 2024 Aug 30;42(21):126182. doi: 10.1016/j.vaccine.2024.126182. Epub 2024 Aug 6.

  PMID: 39116486 DERIVED

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Qinghu Guan

  Guizhou Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 23, 2022
• Study Start: November 27, 2022
• Primary Completion: January 24, 2023
• Study Completion: January 24, 2023
• Last Updated: September 18, 2023

Record last verified: 2022-07

Locations

CN (1)