Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

Phase 4 Completed 3308 enrolled Beijing Center for Disease Control and Prevention

RandomizedParallel-groupDouble-blindPrevention

Summary

The objective of this study was to evaluate the safety and immunogenicity of one inactivated split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.

Timeline

Start: 2011-08
Primary completion: 2011-11
Completion: 2012-12

Publications

Bai Y, Shi N, Lu Q, Yang L, Wang Z, Li L, Han H, Zheng D, Luo F, Zhang Z, Ai X. Immunological persistence of a seasonal influenza vaccine in people more than 3 years old. Hum Vaccin Immunother. 2015;11(7):1648-53. doi: 10.1080/21645515.2015.1037998.
Li S, Li L, Ai X, Yang L, Bai Y, Wang Z, Han H, Lu Q, Luo F, Zhang Z, Liu C, Xiao J, Shi N. A randomized, controlled, blinded study of the safety, immunogenicity and batch consistency of Aleph inactivated split influenza vaccine made in China in Chinese people. Hum Vaccin Immunother. 2014;10(3):557-65. doi: 10.4161/hv.27329. Epub 2013 Dec 3.

Drugs

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

Indications

No indication recorded.