Sponsor study identifier
interventional
30
1 country
1
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2006
Actual (reported)Study Completion
August 2007
Actual (reported)To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains. Observational Objectives: To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2007
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.
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
November 24, 2005
Actual (reported)November 28, 2005
Actual (reported)March 2006
Actual (reported)August 2007
Actual (reported)March 25, 2009
Actual (reported)Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination
GMTs and their 95% Confidence interval are presented for each of the 3 antigens in the Fluzone® vaccine 2005-2006 Pediatric formulation. Post-dose 1 (Influenza vaccine Primed group); post-dose 2 (Influenza vaccine Naive group)
Day 14 post-vaccination
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 1
0 to 3 days post-vaccination 1
Number of Subjects Who Had Solicited Local and Systemic Reactions Post-vaccination 2
0 to 3 days post-vaccination 2
Subjects have never received Influenza virus vaccine in the past
Subjects have received Influenza virus vaccine in the past
0.25 mL, Intramuscular (Day 0 and Day 28)
0.25 mL, Intramuscular (Day 0)
Norfolk, Virginia, 23510, United States
Clinical Trials
Sanofi Pasteur, a Sanofi Company
30 participants (actual enrollment reported by the registry).
First Submitted
November 24, 2005
First Posted
November 28, 2005
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®
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Primary Completion
March 2006
Actual (reported)Study Completion
August 2007
Actual (reported)Last Updated
April 14, 2016
Results First Posted
March 25, 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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