The virus strains responsible for influenza vary in an unpredictable fashion, therefore the type of virus as well as the magnitude of influenza activity changes from one winter to the other. Therefore it?s necessary continuous monitoring of the influenza epidemic by national surveillance systems. Following the recommendations of these surveillance systems, anti-influenza vaccines are produced ad hoc every year and distributed worldwide according to the new variants of the influenza virus. MedDR
Conditions
Sponsors
NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry; 2. able to comply with all the study requirements; 3. in general good health as determined by: medical history;physical examination;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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to: a. Cancer, except for localized skin cancer; b. Advanced congestive heart failure c. Chronic obstructive pulmonary disease (COPD); d. Autoimmune disease (including rheumatoid arthritis); e. Acute or progressive hepatic disease; f. Acute or progressive renal disease; g. Severe neurological or psychiatric disorder h. Severe asthma 2. They have history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate); 3. They have a 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; 4. They have a known or suspected history of drug or alcohol abuse; 5. They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator?s opinion would interfere with the safety of the subject; 6. Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing age do not plan to use acceptable birth control measures, for the duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom or diaphragm), intrauterine device (IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject?s study entry; 7. Within the past 12 months, they have: - received more than one injection of influenza vaccine 8. Within the past 6 months, they have: - had laboratory confirmed influenza disease; - received influenza vaccine; 9. Within the past 4 weeks they have received: - another vaccine; - any investigational agent; 10. They have any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days; 11. They have experienced fever (i.e., axillary temperature≥ 38C) within the last 3 days; 12. They are taking part in another clinical study; 13. They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives; 14. They are severely obese with Body Mass Index (BMI) > 35; 15. Site personnel involved in the evaluation of safety and their immediate relatives are excluded from participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the safety of a single intramuscular (IM) injection of AGRIPPAL S1 in non-elderly 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).;Main Objective: To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in non-elderly 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 hemagglutination inhibition (HI) test for confirmation purposes. (Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. CPMP/BWP/214/96: 12 March 1997)?;Primary end point(s): The following serological assessments should 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 anti-HA antibody titer should be > 40% ▫ Mean geometric increase should be > 2.5 ▫ The proportion of subjects achieving an HI titer ≥ 40 or SRH area ≥ 25 mm2 should be > 70% The following serological assessments should be considered for each strain in elderly subjects, aged over 60, and at least one of the assessments should meet the indicated requirements: ▫ The proportion of subjects achieving seroconversion or significant increase in anti-HA antibody titer should be > 30% ▫ Mean geometric increase should be > 2.0 ▫ The proportion of subjects achieving an HI titer ≥ 40 or SRH area ≥ 25 mm2 should be > 60% | — |
Countries
Italy
Outcome results
None listed