|
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00258830 |
To describe the safety during Days 0 to 21 following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone in subjects aged 18-59 years and subjects aged >=60 years.
To describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in subjects aged 18-59 years and subjects aged >= 60 years.
To submit remaining available sera to CBER for further analysis by FDA, CDC and WHO to support selection and recommendation of antigen strains for subsequent influenza vaccines.
Condition | Intervention | Phase |
Influenza |
Biological: Influenza Virus Vaccine |
Phase IV |
MedlinePlus related topics: | Flu |
ChemIDplus related topics: | Influenza Vaccines Fluvirin |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Enrollment: | 120 |
Study Start Date: | September 2005 |
Study Completion Date: | March 2007 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Biological: Influenza Virus Vaccine
0.5 mL, Intramuscular
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Related Info 
  |
Related Info 
  |
Responsible Party: | Sanofi Pasteur Inc. ( Medical Director ) |
Study ID Numbers: | GRC25 |
First Received: | November 24, 2005 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00258830 |
Health Authority: | United States: Food and Drug Administration |
|
|
|