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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00258817 |
To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains.
Observational Objectives:
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 |
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Influenza |
Biological: Influenza Virus Vaccine (Fluzone®) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2005-2006 Formulation) |
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 |
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Influenza Virus Vaccine Naïve: Experimental
Subjects have never received Influenza virus vaccine in the past
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Biological: Influenza Virus Vaccine (Fluzone®)
0.25 mL, Intramuscular (Day 0 and Day 28)
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Influenza Virus Vaccine-primed: Experimental
Subjects have received Influenza virus vaccine in the past
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Biological: Influenza Virus Vaccine (Fluzone®)
0.25 mL, Intramuscular (Day 0)
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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 Director ) |
Study ID Numbers: | GRC26 |
Study First Received: | November 24, 2005 |
Results First Received: | January 21, 2009 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00258817 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Fluzone® Influenza Virus Vaccine |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Healthy Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |