Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00388583 |
As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly.
Primary Objective:
To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone®.
Secondary Objectives:
Immunogenicity:
To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®.
Safety:
To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.
Condition | Intervention | Phase |
---|---|---|
Orthomyxoviridae Infection Influenza Myxovirus Infection |
Biological: Split, Inactivated, Trivalent Influenza Vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 800 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | August 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
0.1 mL, ID
|
2: Active Comparator
Split, Inactivated, Trivalent Influenza Vaccine
|
Biological: Split, Inactivated, Trivalent Influenza Vaccine
0.5 mL, IM
|
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Note: Use of topical or inhalant corticosteroids is acceptable.
United States, Alabama | |
Alabaster, Alabama, United States | |
United States, Arizona | |
Tucson, Arizona, United States | |
United States, California | |
Fountain Valley, California, United States | |
United States, Florida | |
Pinellas Park, Florida, United States | |
United States, Illinois | |
Chicago, Illinois, United States | |
United States, Missouri | |
Springfield, Missouri, United States | |
United States, New York | |
Brooklyn, New York, United States | |
New York, New York, United States | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States | |
Grove City, Pennsylvania, United States | |
Johnstown, Pennsylvania, United States | |
Bensalem, Pennsylvania, United States | |
United States, Texas | |
Fort Worth, Texas, United States | |
Galveston, Texas, United States | |
United States, Utah | |
Layton, Utah, United States | |
South Jordan, Utah, United States | |
United States, Virginia | |
Norfolk, Virginia, United States |
Study Director: | Clinical Trials | sanofi pasteur |
Responsible Party: | sanofi-aventis ( Sanofi pasteur ) |
Study ID Numbers: | FID04 |
Study First Received: | October 16, 2006 |
Last Updated: | May 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00388583 |
Health Authority: | United States: Food and Drug Administration |
Influenza Orthomyxoviruses Inactivated Split-virion influenza vaccine Elderly. |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
Communicable Diseases RNA Virus Infections Infection |