Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)

Summary

The aim of the study was to assess the immunogenicity and safety of Fluzone Quadrivalent influenza vaccine Southern Hemisphere (SH) 2015 formulation in participants aged 18 to 60 years as well as in participants 61 years or older. The objectives were: * To evaluate the compliance, in terms of immunogenicity, of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation with the requirements of the European Medicines Agency (EMA) Note for guidance (NfG) CPMP/BWP/214/96 * To describe the immunogenicity of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation * To describe the safety of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation

Timeline

Start

2015-06-17

Primary completion

2015-07-17

Completion

2015-07-17

Publications

• Results Montalban C, Montellano MB, Santos J, Lavis N. Immunogenicity and safety of the 2015 Southern Hemisphere formulation of a split-virion inactivated quadrivalent vaccine. Hum Vaccin Immunother. 2018 Mar 4;14(3):593-595. doi: 10.1080/21645515.2017.1377378. Epub 2017 Oct 30.

Drugs

Indications