Sponsor study identifier
interventional
33
1 country
1
Study Start
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2004
Actual (reported)Study Completion
July 2004
Actual (reported)To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 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 findings from Days 0 to 44 following injection of the 2003-2004 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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2004
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.
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
January 2004
Actual (reported)July 2004
Actual (reported)February 3, 2009
Actual (reported)February 4, 2009
Actual (reported)August 27, 2009
Actual (reported)Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination
Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.
Day 0 to 3 post-vaccination
Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection)
Day 0 and Day 14 after Dose 2
Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion)
Day 0 and Day 14 Post-dose 2
Participants received 2 doses of Fluzone® vaccine
0.25 mL, Intramuscular
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Norfolk, Virginia, 23510, United States
Mitchell DK, Ruben FL, Gravenstein S. Immunogenicity and safety of inactivated influenza virus vaccine in young children in 2003-2004. Pediatr Infect Dis J. 2005 Oct;24(10):925-7. doi: 10.1097/01.inf.0000180978.66362.d9.
Medical Director
Sanofi Pasteur Inc.
33 participants (actual enrollment reported by the registry).
First Submitted
February 3, 2009
First Posted
February 4, 2009
Study Start
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine
Contact the study team to confirm eligibility.
Primary Completion
January 2004
Actual (reported)Study Completion
July 2004
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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