Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine

Completed 355 enrolled Fluart Innovative Vaccine Ltd, Hungary

RandomizedParallel-groupSingle-blindPrevention

Summary

To determine the tolerability and immunogenicity of FLUVAL P monovalent influenza vaccine in adults and elderly people, with the objective to verify efficacy and tolerability of the study drug.

Timeline

Start: 2009-08
Primary completion: 2009-09
Completion: 2010-02

Outcome

Met primary endpoint

paper Single doses of 6 microg fulfilled European Union and US licensing criteria for interpandemic and pandemic influenza vaccines. PMID 20018367 ↗

Publications

Vajo Z, Tamas F, Sinka L, Jankovics I. Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial. Lancet. 2010 Jan 2;375(9708):49-55. doi: 10.1016/S0140-6736(09)62039-0. Epub 2009 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluval AB	Vaccine	15 ug	—
Subject	Fluval AB	Vaccine	0.5 ml	—
Subject	Fluval P	Vaccine	6 ug	—
Subject	Fluval P	Vaccine	0.5 ml	—