Sponsor study identifier
interventional
116
1 country
1
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2008
Actual (reported)Study Completion
September 2008
Actual (reported)To submit remaining available sera to Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 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)April 2008
Actual (reported)September 2008
Actual (reported)March 30, 2009
Actual (reported)Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)
0-3 days post-vaccination
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination
GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.
21 days post-vaccination
aged 19 to 59 years
aged ≥ 60 years
Influenza vaccine
Influenza vaccine
Norfolk, Virginia, 23507, United States
Medical Director
Sanofi Pasteur Inc
116 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.
Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine
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
April 2008
Actual (reported)Study Completion
September 2008
Actual (reported)Last Updated
April 14, 2016
Results First Posted
March 30, 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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