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Sponsored by: |
Sanofi-Aventis |
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00258817 |
To provide serum to FDA for use by FDA, CDC, and WHO for characterization of circulating influenza strains.
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.
Condition | Intervention | Phase |
Influenza |
Biological: Influenza Virus Vaccine |
Phase IV |
MedlinePlus related topics: | Flu |
ChemIDplus related topics: | Influenza Vaccines Fluvirin |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Enrollment: | 30 |
Study Start Date: | October 2005 |
Study Completion Date: | August 2007 |
Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Biological: Influenza Virus Vaccine
0.25 mL, Intramuscular
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Ages Eligible for Study: | 6 Months to 36 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Related Info 
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Related Info 
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Responsible Party: | Sanofi Pasteur Inc. ( Medical Director ) |
Study ID Numbers: | GRC26 |
First Received: | November 24, 2005 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00258817 |
Health Authority: | United States: Food and Drug Administration |
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