Trial to Describe the Safety and Immunogenicity of Fluzone®
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00524940|
Recruitment Status : Completed
First Posted : September 5, 2007
Results First Posted : March 30, 2009
Last Update Posted : April 14, 2016
Objective 1:To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere (NH) 2007-2008 formulation.
Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza vaccine NH 2007-2008 formulation.
Objective 3: Serum Collection - To submit remaining available sera to Center for Biologics Evaluation and research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC), and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Inactivated, Split-Virion Influenza Virus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2007-2008 Formulation (Intramuscular Route)|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||December 2007|
|Experimental: Study Group||
Biological: Inactivated, Split-Virion Influenza Virus
0.5 mL, Intramuscular
Other Name: Fluzone®
- Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. [ Time Frame: 0-3 days post-vaccination and entire study duration ]Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.
- Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination. [ Time Frame: 21 days post-vaccination ]GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524940
|United States, Virginia|
|Norfolk, Virginia, United States, 23507|
|Study Director:||Medical Director||Sanofi Pasteur Inc|