Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine

Phase 4

Completed

• Conditions: Influenza

• Registration Number: NCT00831987
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

To observe and to describe the safety during Days 0 to 21 following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.

To measure and to describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.

Detailed Description

The time of onset and duration of local and systemic solicited reactions will be assessed and reported. Unsolicited adverse events (including serious adverse events) will be collected and categorized throughout the study period.

Antibody levels will be evaluated by hemagglutination inhibition (HI) assay from sera obtained pre-vaccination (Day 0) and 21 days post-vaccination, for antigens from the 2004-2005 influenza virus strains: A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2), and B/Jiangsu/10/2003.

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Results First Submitted: 2009-07-20
• Results First Submitted QC: 2009-07-20
• Results First Posted: 2009-08-27
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine	Day 0 and Day 21 Post-Vaccination	GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.
Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination	0 to 3 days post-vaccination	Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site.; Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia
Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination	21 Days post-vaccination
Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination	Day 21 post-vaccination