Safety Study of CSL Limited's Influenza Virus Vaccine in the Paediatric Population Aged >= 6 Months to < 18 Years

Phase 4 Completed 1992 enrolled Seqirus

Non-randomizedSingle-groupOpen-labelPrevention

Summary

A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged \>= 6 Months to \< 18 Years

Timeline

Start: 2009-03
Primary completion: 2010-02
Completion: 2010-02

Publications

Results Lambert SB, Chuk LM, Nissen MD, Nolan TM, McVernon J, Booy R, Heron L, Richmond PC, Walls T, Marshall HS, Reynolds GJ, Hartel GF, Hu W, Lai MH. Safety and tolerability of a 2009 trivalent inactivated split-virion influenza vaccine in infants, children and adolescents. Influenza Other Respir Viruses. 2013 Sep;7(5):676-85. doi: 10.1111/irv.12107. Epub 2013 Apr 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CSL Limited Influenza Virus Vaccine	Vaccine	0.25 ml	—
Subject	CSL Limited Influenza Virus Vaccine	Vaccine	0.5 ml	—

Safety Study of CSL Limited's Influenza Virus Vaccine in the Paediatric Population Aged >= 6 Months to < 18 Years

Summary

Timeline

Publications

Drugs

Indications