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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00772109 |
This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route.
Primary Objective:
Secondary Objectives:
Safety
Condition | Intervention | Phase |
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Orthomyxoviridae Infection Influenza Myxovirus Infection |
Biological: Influenza Virus Vaccine USP Trivalent Types A and B |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years |
Estimated Enrollment: | 3900 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Influenza vaccine Lot 1
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Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
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2: Experimental
Influenza vaccine Lot 2
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Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
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3: Experimental
Influenza vaccine Lot 3
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Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
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4: Active Comparator |
Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
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Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur Inc. ( Medical Monitor ) |
Study ID Numbers: | FID31 |
Study First Received: | October 13, 2008 |
Last Updated: | November 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00772109 |
Health Authority: | United States: Food and Drug Administration |
Influenza Orthomyxoviruses Inactivated Split-virion influenza vaccine Fluzone® Adults |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
Communicable Diseases RNA Virus Infections Infection |