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drugset / Trial / NCT06049927

A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months

NCT06049927 ↗

Phase 3 Completed 3300 enrolled Sinovac Biotech Co., Ltd
RandomizedParallel-groupQuadruple-blindPrevention

Summary

A phase III clinical trial of the study of quadrivalent influenza vaccine developed by Sinovac Biotech will be conducted in Chinese children aged 6 to 35 months. The trial is an randomized, double-blind and active controlled study. The objective of this study is to evaluate the Immunogenicity and safety of the vaccine.

Timeline

Start
2023-09-16
Primary completion
2024-05-23
Completion
2024-05-23

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Quadrivalent influenza vaccine Vaccine 7.5 ug Intramuscular
Subject Quadrivalent influenza vaccine Vaccine 15 ug Intramuscular
Subject Quadrivalent influenza vaccine Vaccine 0.25 ml Intramuscular
Subject Quadrivalent influenza vaccine Vaccine 0.5 ml Intramuscular
Comparator Trivalent influenza vaccine(BV) Vaccine 7.5 ug Intramuscular
Comparator Trivalent influenza vaccine(BV) Vaccine 0.25 ml Intramuscular
Comparator Trivalent influenza vaccine(BY) Vaccine 7.5 ug Intramuscular
Comparator Trivalent influenza vaccine(BY) Vaccine 0.25 ml Intramuscular

Indications

influenza