NCT03859141

Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (7.5μg/0.25ml)

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 6-35 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,340 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy children aged 6-35 months.

Detailed description

The study includes open-labelled phase I and randomized, double-blind, controlled phase III clinical trial. In the phase I, 20 healthy Chinese children aged 6-35 months were administered with two doses of QIV (7.5μg/0.25ml). In the phase Ⅲ clinical trial, 2320 children were assigned to QIV group, TIV (B/Victoria) group and TIV (B/Yamagata) group in a 2:1:1 ratio. All vaccines were manufactured by Sinovac Biotech Co., Ltd.

Conditions

• Seasonal Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent influenza vaccine	One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.
BIOLOGICAL	Quadrivalent influenza vaccine	One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.
BIOLOGICAL	Trivalent influenza vaccine (contains B/Victoria strain)	One dose of trivalent influenza vaccine (contains B/Victoria strain): 0.25 ml per dose containing 7.5μg antigen.
BIOLOGICAL	Trivalent influenza vaccine (contains B/Yamagata strain)	One dose of trivalent influenza vaccine (contains B/Yamagata strain): 0.25 ml per dose containing 7.5μg antigen.

Timeline

• Start date: 2018-02-06
• Primary completion: 2018-04-17
• Completion: 2018-11-02
• First posted: 2019-03-01
• Last updated: 2019-03-01

Locations

2 sites across 1 country: China