Sponsor study identifier
interventional
120
1 country
1
Study Start
August 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2006
Actual (reported)Study Completion
February 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2004
Date type not reportedThis date has not been verified as actual or estimated.
February 2006
Actual (reported)February 2006
Actual (reported)January 28, 2009
Actual (reported)January 29, 2009
Actual (reported)August 27, 2009
Actual (reported)Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® 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
0 to 3 days post-vaccination
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine
GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.
Day 0 and Day 21 Post-Vaccination
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
Participants aged 18 to 59 years at enrollment and received 1 dose of Fluzone® Vaccine
Participants aged at least 60 years or older at enrollment and received 1 dose of Fluzone® Vaccine
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Norfolk, Virginia, 23507, United States
Medical Director
Sanofi Pasteur Inc.
120 participants (actual enrollment reported by the registry).
First Submitted
January 28, 2009
First Posted
January 29, 2009
Study Start
August 2004
Date type not reportedThis date has not been verified as actual or estimated.
Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
February 2006
Actual (reported)Study Completion
February 2006
Actual (reported)Last Updated
April 14, 2016
Results First Posted
August 27, 2009
Record last verified: 2016-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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