Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older

Phase 3

Terminated

• Conditions: Influenza
• Interventions: Biological: Trivalent inactivated influenza vaccine High Dose; Biological: Trivalent inactivated influenza vaccine

• Registration Number: NCT00976027
• Lead Sponsor: Sanofi

Brief Summary

The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of Fluzone® vaccine in the elderly.

Primary objective:

To measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed influenza caused by viral types/subtypes that are antigenically similar to those contained in the respective annual vaccine formulations.

Secondary objectives:

* To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused by any type or subtype of influenza virus.

* To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations.

Detailed Description

The occurrence of influenza-like illness (ILI) will be determined in elderly participants vaccinated with either Fluzone High Dose or Fluzone® vaccine.

The presence of influenza virus in the respiratory tract of vaccinated individuals with ILI will be confirmed by two methods.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Primary Completion: 2011-05
• Study Completion: 2012-04
• Results First Submitted: 2012-06-19
• Results First Submitted QC: 2012-06-19
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-24
• Results First Posted: 2012-07-25
• Last Update Posted: 2012-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9172

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluzone® High Dose Group	Trivalent inactivated influenza vaccine High Dose	-
Fluzone® Group	Trivalent inactivated influenza vaccine	-

Primary Outcome Measures

Name	Time	Method
Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations.	Day 0 (pre-vaccination) up to Year 1 post-vaccination	The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.