NCT01011049

Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM

Safety and Immunogenicity of Revaccination With Influenza Vaccine in Healthy Adult Subjects Aged 18 to 64 Years Who Were Previously Vaccinated With Fluzone ID or Fluzone IM

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,250 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine. Primary Objective: * To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants. Secondary Objective: * To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.

Detailed description

All participants, who previously received either Fluzone ID or Fluzone IM in Study FID31 (NCT 00772109), will receive one dose of either the same or the alternative vaccine.

Conditions

• Influenza

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

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-05-01
• Completion: 2010-10-01
• First posted: 2009-11-11
• Last updated: 2016-04-14
• Results posted: 2011-08-11

Locations

45 sites across 2 countries: United States, Puerto Rico