NCT05512494

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

A Randomized, Double-blind Clinical Trial to Evaluate Lot-to-lot Consistency , Immunogenicity and Safety of Quadrivalent Influenza Vaccine (Split Virion), Inactivated in Health Populations Aged 9~59 Years Old

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,260 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 9 Years – 59 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a randomized, double-blind phase Ⅳ clinical trial in health subjects aged 9-59 years old to evaluate the lot-to-lot consistency,immunogenicity and safety of quadrivalent influenza vaccine (Split Virion), inactivated.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 1260 subjects,including 360 subjects aged 9-17 years and 900 subjects aged 18-59 years will be enrolled.The subjects in each age group will be randomly divided into three groups in a ratio of 1:1:1 to receive one dose of three lots of quadrivalent influenza vaccine (Split Virion), inactivated produced on a commercial scale,respectively.

Conditions

• Seasonal Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Influenza Vaccine (Split Virion), inactivated	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.

Timeline

• Start date: 2022-11-27
• Primary completion: 2023-01-24
• Completion: 2023-01-24
• First posted: 2022-08-23
• Last updated: 2023-09-18

Locations

1 site across 1 country: China