NCT01258595

A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age

Safety and Immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 50 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age Primary Objective: * To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV. * To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2

Detailed description

Participants will be randomized to receive one dose of either High-Dose Trivalent Inactivated Influenza Vaccine or Trivalent Inactivated Influenza Vaccine. They will be followed up for safety for one month post-vaccination.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	High-Dose Trivalent Inactivated Influenza Vaccine	0.5 mL Intramuscular
BIOLOGICAL	Trivalent Inactivated Influenza Vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-03-01
• Completion: 2011-04-01
• First posted: 2010-12-13
• Last updated: 2016-05-16
• Results posted: 2011-10-27

Locations

5 sites across 1 country: United States