NCT00775450

Influenza Vaccine Revaccination in Ambulatory Elderly Subjects

Safety and Immunogenicity of Revaccination With Influenza Vaccine in Ambulatory Elderly Subjects Previously Vaccinated With Fluzone ID, Fluzone HD, and Fluzone® IM

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 807 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years. Primary Objective: To describe the safety profile for all subjects. Secondary Objective: To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.

Detailed description

Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.

Conditions

• Influenza
• Orthomyxovirus Infection
• 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	0.5 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
BIOLOGICAL	Influenza Virus Vaccine USP Trivalent Types A and B	0.5 mL, Intramuscular

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-06-01
• Completion: 2009-07-01
• First posted: 2008-10-20
• Last updated: 2013-12-31
• Results posted: 2011-08-11

Locations

28 sites across 1 country: United States