NCT03853993

Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)

Open Phase I and Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged Over 3 Years.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,380 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged over 3 years

Detailed description

This study is a phase I\& III clinical trial. Phase I is open-labelled, and phase III is randomized, double-blind, active-controlled. The purpose of this study is to evaluate the safety and immunogenicity of the quadrivalent influenza vaccine (QIV) (experimental vaccine) manufactured by Sinovac Biotech Co., Ltd in subjects aged over 3 years. In phase I, 60 volunteers received single dose QIV (15µg/0.5ml). In phase III, 2320 volunteers were assigned to receive single dose QIV (15µg/0.5ml) or two commercial trivalent influenza vaccines (TIVs) (15µg/0.5ml) in a ratio of 2:1:1. The commercial TIVs were also manufactured by Sinovac Biotech Co., Ltd.

Conditions

• Seasonal Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent influenza vaccine	Received single dose QIV (15µg/0.5ml)
BIOLOGICAL	Trivalent influenza vaccine (contains B/Victoria strain)	Received single dose TIV which contains B/Victoria strain (15µg/0.5ml)
BIOLOGICAL	Trivalent influenza vaccine (contains B/Yamagata strain)	Received single dose TIV which contains B/Yamagata strain (15µg/0.5ml)

Timeline

• Start date: 2018-01-23
• Primary completion: 2018-08-17
• Completion: 2018-10-08
• First posted: 2019-02-26
• Last updated: 2019-02-27

Locations

2 sites across 1 country: China