A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: Influenza virus vaccine

• Registration Number: NCT00835926
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.

To describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.

Detailed Description

Safety will be assessed throughout the trial period. Using antigens provided by Aventis Pasteur Inc., pre- and post-vaccination serum antibody titers for each of the three vaccine strains will be measured.

Study Timeline

• Study Start: 2003-07
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Results First Submitted: 2009-09-23
• Results First Submitted QC: 2009-09-23
• Results First Posted: 2009-10-26
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluzone® Vaccine Group 1	Influenza virus vaccine	Participants aged 18 to 59 years at enrollment - Fluzone® Group
Fluzone® Vaccine Group 2	Influenza virus vaccine	Participants aged 60 years and older at enrollment - Fluzone® Group

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®	Days 0 to 3 Post-vaccination	Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site.; Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®	Day 0 and Day 21 Post-vaccination	Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.
Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®	Day 21 Post-vaccination	Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.
Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®	Day 21 Post-vaccination	Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay