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Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00391391 |
Primary Objective:
To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
Secondary Objectives:
Condition | Intervention | Phase |
---|---|---|
Orthomyxoviridae Infection Influenza Myxovirus Infection |
Biological: Split, Inactivated, Trivalent Influenza Vaccine Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 600 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | September 2008 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Split, Inactivated, Trivalent Influenza Vaccine
|
Biological: Split, Inactivated, Trivalent Influenza Vaccine
Vaccine (infant dose)
|
2: Experimental
Split, Inactivated, Trivalent Influenza Vaccine
|
Biological: Split, Inactivated, Trivalent Influenza Vaccine
Vaccine (children dose)
|
3: Active Comparator
Split, Inactivated, Trivalent Influenza Vaccine
|
Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Vaccine (infant dose)
|
4: Active Comparator
Split, Inactivated, Trivalent Influenza Vaccine
|
Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Vaccine (children dose)
|
Ages Eligible for Study: | 6 Months to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
United States, Arkansas | |
Little Rock, Arkansas, United States | |
Harrisburg, Arkansas, United States | |
Trumann, Arkansas, United States | |
United States, California | |
Paramount, California, United States | |
Bellflower, California, United States | |
Downey, California, United States | |
Fountain Valley, California, United States | |
United States, Kentucky | |
Owensboro, Kentucky, United States | |
United States, Louisiana | |
Bossier City, Louisiana, United States | |
Shreveport, Louisiana, United States | |
United States, Minnesota | |
Brainerd, Minnesota, United States | |
United States, Ohio | |
Cleveland, Ohio, United States | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States | |
Wexford, Pennsylvania, United States | |
Uniontown, Pennsylvania, United States | |
Erie, Pennsylvania, United States | |
United States, Texas | |
Fort Worth, Texas, United States | |
United States, Utah | |
Salt Lake City, Utah, United States |
Study Director: | Clinical Trials | sanofi pasteur |
Responsible Party: | sanofi aventis ( sanofi pasteur ) |
Study ID Numbers: | FID07 |
Study First Received: | October 23, 2006 |
Last Updated: | May 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00391391 |
Health Authority: | United States: Food and Drug Administration |
Influenza Orthomyxoviruses Inactivated Split-virion influenza vaccine Infants children. |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
Communicable Diseases RNA Virus Infections Infection |