NCT01215669

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed description

All participants will receive a single dose of study vaccine on Day 0. Immunogenicity data will be collected before vaccination and on Day 21 post vaccination. Safety will be assessed throughout the study.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	IDflu™: Split virion inactivated influenza vaccine	Single dose 0.1 mL, intradermal
BIOLOGICAL	Vaxigrip®: Split virion inactivated influenza vaccine	Single dose 0.5 mL, intramuscular
BIOLOGICAL	IDflu™: Split virion inactivated influenza vaccine	Single dose 0.1 mL, intradermal
BIOLOGICAL	Vaxigrip®: Split virion inactivated influenza vaccine	Single dose 0.5 mL, intramuscular

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-02-01
• Completion: 2011-04-01
• First posted: 2010-10-06
• Last updated: 2018-09-13

Locations

2 sites across 1 country: South Korea