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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00389857 |
To provide CBER with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by FDA, CDC and WHO.
Condition | Intervention | Phase |
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Influenza Vaccines |
Biological: Influenza Virus Vaccine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Enrollment: | 31 |
Study Start Date: | October 2006 |
Study Completion Date: | July 2008 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: Influenza Virus Vaccine
0.25 mL, Intramuscular (infant/children dose)
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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:
Responsible Party: | Sanofi Pasteur Inc. ( Medical Monitor ) |
Study ID Numbers: | GRC34 |
Study First Received: | October 18, 2006 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00389857 |
Health Authority: | United States: Food and Drug Administration |
Influenza Vaccine |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections |