Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects

Phase 2

Completed

• Conditions: Influenza; Orthomyxoviruses; Myxovirus Infection
• Interventions: Biological: Influenza virus vaccine - cell based (2007-2008 Formulation); Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation); Biological: Influenza virus vaccine (2007-2008 Formulation)

• Registration Number: NCT00845429
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Secondary Objective:

To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Detailed Description

This is a multi-center study in healthy adult subjects. All subjects will receive a single dose of one of the influenza vaccine formulations and will provide blood samples for immunogenicity assessment.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-08
• Study Completion: 2008-11
• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-18
• Results First Submitted: 2012-11-17
• Results First Submitted QC: 2012-11-17
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-13
• Results First Posted: 2012-12-17
• Last Update Posted: 2012-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 729

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Standard-dose Cell-based Influenza Vaccine	Influenza virus vaccine - cell based (2007-2008 Formulation)	Participants will receive a single dose of standard-dose cell-based influenza virus vaccine.
Group 2: High-dose Cell-based Influenza Vaccine	Influenza virus vaccine - cell-based (2007-2008 Formulation)	Participants will receive a single dose of high-dose cell-based influenza virus vaccine.
Group 3: Licensed Fluzone® Influenza Vaccine	Influenza virus vaccine (2007-2008 Formulation)	Participants will receive a single dose of licensed Fluzone® influenza vaccine.

Primary Outcome Measures

Name	Time	Method
Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.	Days 0 and 21 post-vaccination
Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.	Day 21 post-vaccination	Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)
Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.	Day 21 post-vaccination	Seroconversion: For participants with a Day 0 pre-vaccination titer \< 10 (1/dil), titer ≥ 40 (1/dil) on Day 21.; Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.	Day 0 up to Day 7 post-vaccination	Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration.; Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors.