Sponsor study identifier
interventional
121
1 country
1
Study Start
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2003
Actual (reported)Study Completion
September 2003
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2003
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.
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
September 2003
Actual (reported)September 2003
Actual (reported)January 27, 2009
Actual (reported)February 4, 2009
Actual (reported)October 26, 2009
Actual (reported)Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
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
Days 0 to 3 Post-vaccination
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®
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.
Day 0 and Day 21 Post-vaccination
Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®
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.
Day 21 Post-vaccination
Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®
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
Day 21 Post-vaccination
Participants aged 18 to 59 years at enrollment - Fluzone® Group
Participants aged 60 years and older at enrollment - Fluzone® Group
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Norfolk, Virginia, 23507, United States
Medical Director
Sanofi Pasteur Inc.
121 participants (actual enrollment reported by the registry).
First Submitted
January 27, 2009
First Posted
February 4, 2009
Study Start
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 2003
Actual (reported)Study Completion
September 2003
Actual (reported)Last Updated
April 14, 2016
Results First Posted
October 26, 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.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: