Sponsor study identifier
interventional
31
1 country
1
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2007
Actual (reported)Study Completion
July 2008
Actual (reported)To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2008
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 2006
Date type not reportedThis date has not been verified as actual or estimated.
October 18, 2006
Actual (reported)October 19, 2006
Actual (reported)September 2007
Actual (reported)July 2008
Actual (reported)March 24, 2009
Actual (reported)Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination
GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone vaccine 2006-2007 Pediatric formulation. Post-dose 1 (Influenza vaccine-primed group); Post-dose 2 (Influenza vaccine-naive group)
14 days post-vaccination
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 1.
0 to 3 days post-vaccination 1
Number of Participants Who Had Solicited Injection Site and Systemic Reactions Post-vaccination 2.
0 to 3 days post-vaccination 2
Participants have never received Influenza virus vaccine in the past. They will receive a single dose of Fluzone vaccine on Day 0 and Day 28, respectively.
Participants have received Influenza virus vaccine in the past. They will receive a single dose of Fluzone vaccine on Day 0.
0.25 mL, Intramuscular (infant/children dose)
0.25 mL, Intramuscular (infant/children dose)
Norfolk, Virginia, 23510, United States
Medical Director
Sanofi Pasteur Inc.
31 participants (actual enrollment reported by the registry).
First Submitted
October 18, 2006
First Posted
October 19, 2006
Study Start
October 2006
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 2007
Actual (reported)Study Completion
July 2008
Actual (reported)Last Updated
April 14, 2016
Results First Posted
March 24, 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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