Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

Summary

This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.

Timeline

Start

2007-04

Primary completion

2007-07

Completion

2007-12

Publications

• Tregnaghi MW, Stamboulian D, Vanadia PC, Tregnaghi JP, Calvari M, Fragapane E, Casula D, Pellegrini M, Groth N. Immunogenicity, safety, and tolerability of two trivalent subunit inactivated influenza vaccines: a phase III, observer-blind, randomized, controlled multicenter study. Viral Immunol. 2012 Jun;25(3):216-25. doi: 10.1089/vim.2011.0063.

Drugs

Indications