Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to Elderly Subjects

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008

• Registration Number: NCT00522236
• Lead Sponsor: Novartis Vaccines

Brief Summary

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Study First Submitted: 2007-08-28
• Study First Submitted QC: 2007-08-28
• Study First Posted: 2007-08-29
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-24
• Last Update Posted: 2012-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 65 years of age or older

Exclusion Criteria

• any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
• hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin or any other component of the vaccine
• history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
• known or suspected (or high risk of developing) impairment/alteration of immune function
• any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days
• fever within the past 3 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008	-

Primary Outcome Measures

Name	Time	Method
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)	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; 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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (≥ 65 years).	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).

Trial Locations

Locations (2)

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