Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to Elderly Subjects
|Influenza||Biological: Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Elderly Subjects|
- Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (≥65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96) [ Time Frame: 21 days post-vaccination ]
The measures of immunogenicity for each antigen are:
- the geometric mean area (GMA) on Day 0 and Day 21
- the Day 21/Day 0 geometric mean area ratio (GMR)
- the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2
the percentage of subjects achieving an SRH area ≥ 25 mm2 on Day 0 and Day 21
- Seroconversion is defined as negative prevaccination serum/postvaccination serum area ≥ 25 mm2.
- Significant increase in antibody titer is defined as at least a 50% increase in area.
- To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (≥ 65 years). [ Time Frame: 3 days, respectively 21 days post-vaccination ]
Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).
|Study Start Date:||June 2007|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
|Experimental: Arm 1||
Biological: Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008
A single 0.5mL dose of Novartis adjuvanted subunit influenza vaccine, Fluad contained 45μg of viral hemagglutinin, composed of 15μg of the three influenza antigens:
The vaccine is a milky liquid, and was packaged in ready to use, single dose syringes.
A single dose of FLUAD vaccine was administered intramuscularly, preferably in the deltoid muscle of the non dominant arm.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522236
|Dipartimento di Medicina e Scienze dell'Invecchiamento|
|Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, Via S. Spaventa, 37|
|Lanciano, Italy, 66034|
|Study Chair:||Novartis Vaccines||Novartis Vaccines|