Clinical Trial on healthy volunteers (Active immunisation against influenza in the elderly (65 years of age and over), especially for those with an increased risk of associated complications (i.e. patients affected by underlying chronic diseases including diabetes, cardiovascular and respiratory diseases)). MedDRA version: 14.1 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: FLUAD*1SIR 0,5ML C/A 2011-2012
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: INFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED)
Concentration unit: µg microgram(s)
Conce
Sponsors
NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female volunteers of 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry; 2. Individuals able to comply with all the study requirements; 3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 63
Exclusion criteria
Exclusion criteria: -Individuals with behavioral or cognitive impairment or psychiatric disease -Individuals with any serious chronic or acute disease -Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine. -Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function - Individuals with known or suspected history of drug or alcohol abuse. -Individuals with known or suspected history of drug or alcohol abuse. -Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator’s opinion would interfere with the safety of the subject. -Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study. -Individuals with history or any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study. -Individuals who within the past 6 months have: - had any laboratory confirmed seasonal or pandemic influenza disease; - received any seasonal or pandemic influenza vaccine. -Individuals who received any other vaccine within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine during the study. -Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days. -Individuals that have experienced fever (i.e., axillary temperature = 38°C) within the last 3 days of intended study vaccination. -Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. -Individuals who are part of study personnel or close family members conducting this trial -BMI > 35 kg/m2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Safety Endpoints Safety will be assessed in accordance with available safety data on influenza vaccines: -Local and systemic reactions will be assessed for 3 days post the day of vaccination -AEs Days 1 to 4. From Day 5 to study end AEs necessitating a physician’s visit or consultation and/or leading to premature study discontinuation and SAEs. Immunogenicity Endpoints The following serological assessments will be considered for each strain in elderly subjects, aged 65 years and over, and at least one of the assessments should meet the indicated requirements: - Proportion of seroconversion or significant increase in HI titer or SRH area >30% - Mean geometric increase >2.0 - The proportion of subjects achieving an HI titer =40 or SRH area =25 mm2 should be > 60% Circulating anti-HA antibodies will be measured by SRH and possibly HI assay just prior to vaccination (Day 1) and approximately 3 weeks after the vaccination (Day 22). For the purposes of calculation, any HI result <10 (i.e. undetectable) will be expressed as 5, and any negative SRH result will be expressed as 4 mm2. In HI tests, seroconversion or significant increase in antibody titer corresponds to: -negative pre-vaccination serum / post-vaccination serum titer =40 or -at least a four-fold increase in titer from positive pre-vaccination serum In SRH tests, seroconversion or significant increase in antibody titer corresponds to: -negative pre-vaccination serum / post-vaccination serum area =25 mm2 -at least a 50% increase in area from positive pre-vaccination serum di almeno il 50% dell’area rispetto al siero pre-vaccinazione positivo;Timepoint(s) of evaluation of this end point: 21 days after vaccination;Main Objective: To evaluate the safety of a single intramuscular (IM) injection of Fluad in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Belgium, Italy
Contacts
Public ContactClinical Reasearch Development SE
NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
Outcome results
None listed