Prophylaxis of influenza MedDRA version: 14.1 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Fluvirin® Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur
Product Name: Fluvirin® Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur
Pharmaceutical Form: Suspension for inject
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female volunteers of 18 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 63 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 63
Exclusion criteria
Exclusion criteria: 1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study. 2. Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to: - Medically significant Cancer (except for benign or localized skin cancer, cancer in remission for =10 years or localized prostate cancer that has been clinically stable for more than 2 years without treatment) - Medically significant advanced congestive heart failure (ie. NYHA class III and IV) - Chronic obstructive pulmonary disease (COPD; i.e., GOLD Stage III and IV) - Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's thyroiditis that has been clinically stable for = 5 years) - Diabetes mellitus type I; - Poorly controlled diabetes mellitus type II; - Advanced arteriosclerotic disease; - History of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down’s syndrome); - Acute or progressive hepatic disease; - Acute or progressive renal disease; - Severe neurological (es. Guillain–Barré syndrome) or psychiatric disorder; - Severe asthma. 3. 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 (e.g. to eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate). 4. Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from: - receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; - receipt of immunostimulants; - receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; - suspected or known HIV infection or HIV-related disease. 5. Individuals with known or suspected history of drug or alcohol abuse. 6. 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. 7. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study. 8. 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. 9. Individuals who within the past 6 months have: - had any laboratory confirmed seasonal or pandemic influenza disease; - received any seasonal or pandemic influenza vaccine. 10. 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. 11. Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days. 12. Individuals that have experienced fever (i.e., axillary temperature = 38°C) within the last 3 days of intended study vaccination. 13. Individuals participating in any clinical trial with another investigational product 4 weeks prior to first s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety Objectives: To evaluate the safety of a single intramuscular (IM) injection of Fluvirin in adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96). Primary To evaluate the antibody response to each influenza vaccine antigen, as measured by hemagglutination inhibition (HI) at approximately 21 days post-immunization in adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines. Antibodies maybe additionally quantified using the Single Radial Hemolysis (SRH) test for confirmation purposes (Note for Guidance on Harmonization of Requirements for Influenza Vaccines CPMP/BWP/214/96: 12 March 1997). ;Secondary Objective: not applicable;Primary end point(s): Immunogenicity Endpoints The following serological assessments will be considered for each strain in non-elderly adult subjects, aged between 18 and 60, and at least one of the assessments should meet the indicated requirements: - The proportion of subjects achieving seroconversion or significant increase in HI titer or SRH area >40% - Mean geometric increase >2.5 - The proportion of subjects achieving an HI titer =40 or SRH area =25 mm2 should be >70% The following serological assessments will be considered for each strain in elderly subjects, aged 60 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 HI and possibly SRH 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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. ;Timepoint(s) of evaluation of this end point: end of trial day 22. | — |
Countries
Germany
Contacts
Public Contacthead of Central and Northern Europe
Novartis vaccines and Diagnostics GmbH
Outcome results
None listed