drugset / Trial / NCT03853993

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

NCT03853993 ↗

Phase 3 Completed 2380 enrolled Sinovac Biotech Co., Ltd
RandomizedParallel-groupDouble-blindPrevention

Summary

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

Timeline

Start
2018-01-23
Primary completion
2018-08-17
Completion
2018-10-08

Outcome

Met primary endpoint

paper The investigational IIV4 was non-inferiority to IIV3 for the four strains, meanwhile superior to IIV3 for additional B strains (B/BV, B/BY). PMID 32732142 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Quadrivalent influenza vaccine Vaccine 15 ug —
Comparator Trivalent influenza vaccine (contains B/Victoria strain) Vaccine 15 ug —
Comparator Trivalent influenza vaccine (contains B/Yamagata strain) Vaccine 15 ug —

Indications