drugset / Trial / NCT04997239

A Clinical Trial of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old

NCT04997239

Phase 4 Completed 600 enrolled Sinovac Biotech Co., Ltd
RandomizedParallel-groupOpen-labelPrevention

Summary

This is an open-label, randomized and controlled phase Ⅳ clinical trial of quadrivalent influenza vaccine manufactured by Sinovac Biotech Co. , the purpose of this study is to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine with that of 2 doses in vaccine-unprimed children aged 3-8 years old,to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children and to compare the immunogenicity and safety after 2 doses of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children.

Timeline

Start
2021-10-10
Primary completion
2021-10-30
Completion
2021-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Quadrivalent influenza vaccine Vaccine 15 ug Intramuscular

Indications