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| Sponsored by: |
Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00391391 |
Purpose
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)
|
Eligibility| Ages Eligible for Study: | 6 Months to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Contacts and Locations| 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 |
More Information
| 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 History of Changes |
| 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 |
|
Virus Diseases Communicable Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections Infection |