Immunogenicity, Tolerability and Safety of One or Two Doses of an Adjuvanted Swine-origin A H1N1 Influenza Vaccine in Healthy Subjects 18 or More Years of Age Both Vaccinated and Not Yet Vaccinated Against Seasonal Influenza 2009/10

Phase 2 Completed 418 enrolled Novartis Vaccines

Non-randomizedParallel-groupOpen-labelPrevention

Summary

This present study, a phase II, open label study will evaluate the immunogenicity, tolerability and safety of an adjuvanted, inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in healthy subjects aged 18 years and above. This study will explore the effect of the previous and concomitant exposure to a seasonal influenza vaccination to the immunogenicity and safety profile of two different doses of an adjuvanted H1N1sw vaccine.

Timeline

Start: 2009-08
Primary completion: 2009-10
Completion: 2009-11

Outcome

Met primary endpoint

paper All adult and elderly groups met all the European CHMP licensing criteria for H1N1v PMID 20039974 ↗

Publications

Results Gasparini R, Schioppa F, Lattanzi M, Barone M, Casula D, Pellegrini M, Veitch K, Gaitatzis N. Impact of prior or concomitant seasonal influenza vaccination on MF59-adjuvanted H1N1v vaccine (Focetria) in adult and elderly subjects. Int J Clin Pract. 2010 Mar;64(4):432-8. doi: 10.1111/j.1742-1241.2009.02309.x. Epub 2009 Dec 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Monovalent A/H1N1 influenza vaccine	Vaccine	3.75 ug	—
Subject	Monovalent A/H1N1 influenza vaccine	Vaccine	7.5 ug	—