To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
56
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: * A(H1N1) strain: IVR-145 (Solomon Island/3/2006 - like strain) * A(H3N2) strain: NYMC X-161B (A/Wisconsin/67/2005-like strain) * B strain: (B/Malaysia/2506/2004-like strain) in accordance with the recommendations of the World Health Organization, the EU and the national Regulatory Agencies for the 2007/2008 season. 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.
Dipartimento di Medicina e Scienze dell'Invecchiamento
Chieti, Italy
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, Via S. Spaventa, 37
Lanciano, Italy
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)
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 1. Seroconversion is defined as negative prevaccination serum/postvaccination serum area ≥ 25 mm2. 2. Significant increase in antibody titer is defined as at least a 50% increase in area.
Time frame: 21 days post-vaccination
To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (≥ 65 years).
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).
Time frame: 3 days, respectively 21 days post-vaccination
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