drugset / Trial / NCT01215669

Study of Sanofi Pasteur's Intradermal Influenza Vaccine (IDflu™) in Adults and Elderly in Korea

NCT01215669

Phase 4 Completed 240 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupOpen-labelPrevention

Summary

This study is designed to assess the immunogenicity and safety of the 2010-2011 NH season formulation of intradermal (ID) influenza vaccine as part of a post registration commitment. Objectives: * For all groups, to evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) or intramuscular (IM) influenza vaccine Northern Hemisphere (NH) 2010 2011 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 * For all groups, to describe the safety

Timeline

Start
2010-10
Primary completion
2011-02
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject IDflu Vaccine 0.1 ml Intravenous
Comparator Influenza Virus Vaccine Vaccine 0.5 ml Intramuscular

Indications