Dataset from Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Subjects Aged 18 to 60 Years in the Republic of Korea

The aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza
vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern
Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the
Republic of Korea for the registration of the QIV by the Ministry of Food and Drug Safety.

Objectives:

- To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016
seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH
2015-2016 formulation, with the requirements of the Committee for Medicinal Products for
Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed.

- To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016
seasonal formulations