Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine in China

Phase 4 Completed 3105 enrolled Ab&B Bio-tech Co., Ltd.JS Jiangsu Province Centers for Disease Control and Prevention · collab

NaSingle-groupOpen-labelPrevention

Summary

This study evaluates the safety of the quadrivalent subunit influenza vaccine in individuals aged 3 years and older in Jiangsu Province, China. The primary objectives are to assess the occurrence of very rare adverse reactions (incidence \<0.01%), investigate the incidence of cerebral infarction following vaccination, and evaluate the incidence of systemic adverse events among participants aged 9 to 17 years.

Timeline

Start: 2024-11-15
Primary completion: 2025-05-29
Completion: 2025-05-29

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	quadrivalent subunit influenza vaccine	Vaccine	0.5 ml	Intramuscular

Indications

No indication recorded.