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Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years

Influenza Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial Description

All subjects will receive one dose of either QIV or TIV on Day 0. They will be monitored for safety and immunogenicity for up to Day 21 post-vaccination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02550197
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date September 2015
Completion date July 2016
View Details
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