Sponsor study identifier
interventional
30
1 country
1
Study Start
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2006
Actual (reported)Study Completion
April 2006
Actual (reported)To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, 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 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, 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.
April 2006
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
April 2006
Actual (reported)April 2006
Actual (reported)January 28, 2009
Actual (reported)January 29, 2009
Actual (reported)August 27, 2009
Actual (reported)Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation
Solicited local reactions: Erythema, bruising, induration, pain at injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection.
Days 0-3 Post-dose
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation
14 days post-vaccination
Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)
14 days post-vaccination
Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion)
Day 14 post-vaccination
Participants aged ≥ 6 to \< 12 months at enrollment and received 2 doses of Fluzone® Vaccine
Participants aged ≥ 12 to \< 36 months at enrollment and received 2 doses of Fluzone® vaccine
0.25 mL (Day 0 and Day 28), Intramuscular
0.25 mL (Day 0 and Day 28), Intramuscular
Norfolk, Virginia, 23510, United States
Medical Director
Sanofi Pasteur Inc.
30 participants (actual enrollment reported by the registry).
First Submitted
January 28, 2009
First Posted
January 29, 2009
Study Start
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Immunogenicity of the 2005-2006 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
April 2006
Actual (reported)Study Completion
April 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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