NCT00776438

Study of Immune Response in Adults and Elderly Subjects Vaccinated With Inactivated Influenza Vaccines

Evaluation of the Cellular, Humoral and Mucosal Immune Response in Adults and Elderly Subjects Vaccinated Either With an Inactivated Influenza Vaccine Administered Via the Intradermal Route or an Inactivated Influenza Vaccine Administered Via the Intramuscular Route

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations. Objectives: * To describe the immune response per age group and vaccine group after vaccination. * To describe the safety of the vaccines per age group and per vaccine group after vaccination.

Conditions

• Influenza
• Orthomyxovirus Infections
• Myxovirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated, split-virion, influenza vaccine	0.1 mL, Intradermal
BIOLOGICAL	Inactivated, split-virion, influenza vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Inactivated, split-virion influenza vaccine	0.1 mL, Intradermal
BIOLOGICAL	Inactivated, split-virion influenza vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-02-01
• Completion: 2009-04-01
• First posted: 2008-10-21
• Last updated: 2015-06-17

Locations

1 site across 1 country: France