NCT00772109

Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,292 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route. Primary Objective: * To demonstrate lot consistency of the Fluzone ID manufacturing process. * To provide information concerning the immune response of Fluzone ID. Secondary Objectives: Safety * To describe the safety profile of subjects who receive of Fluzone ID.

Detailed description

Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.

Conditions

• Orthomyxoviridae Infection
• Influenza
• Myxovirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Virus Vaccine USP Trivalent Types A and B	0.1 mL, Intradermal
BIOLOGICAL	Influenza Virus Vaccine USP Trivalent Types A and B	0.1 mL, Intradermal
BIOLOGICAL	Influenza Virus Vaccine USP Trivalent Types A and B	0.1 mL, Intradermal
BIOLOGICAL	Influenza Virus Vaccine USP Trivalent Types A and B	0.5 mL, Intramuscular

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-05-01
• Completion: 2009-07-01
• First posted: 2008-10-15
• Last updated: 2016-04-14
• Results posted: 2011-08-10

Locations

49 sites across 2 countries: United States, Puerto Rico