Active influenza immunoprofilaxis MedDRA version: 9.1 Level: LLT Classification code 10059429 Term: Influenza immunisation
Conditions
Interventions
Trade Name: AGRIPPAL S1*1SIR 0,5ML 06-07
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Influenza, purified antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Co
Sponsors
NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult volunteers who are: 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: (i)medical history; (ii)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. subjects who have any serious disease such as: · cancer (leukemia, lymphomas, neoplasm) except for benign or localized skin cancer and non metastatic prostate cancer not presently treated with chemotherapy; · autoimmune disease (including rheumatoid arthritis); · 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; 2. who are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate or any other component of the vaccine; 3. who have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine; 4. who 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 cortical steroid 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. who have a known or suspected history of drug or alcohol abuse; 6. who have 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. women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days); 8. who, within the past 12 months, have: · received more than one injection of influenza vaccine; 9. who, within the past 6 months, have: · had laboratory confirmed influenza disease; · received influenza vaccine; 10. who, within the past 4 weeks have received: · another vaccine; · any investigational agent; 11. who, within the past 7 days, have experienced: · any acute disease; · infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable); 12. who have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days; 13. who, within the past 3 days have experienced: · fever (i.e., axillary temperature ≥ 38°C); 14. who are taking part in another clinical study; 15. who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective. 16. Women who are breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-vaccination in non-elderly adult and elderly subjects in compliance with the requirements of the current EU recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).;Secondary Objective: To evaluate the safety of the administration of a single intramuscular (IM) injection of AGRIPPAL S1 in non-elderly adult and elderly subjects.;Primary end point(s): At least one of the following assessments should meet the indicated requirements for each strain: · Non-elderly adult subjects 18-60 years (i.e., ³ 18 and 40% - mean geometric increase > 2.5 - the proportion of subjects achieving an SRH area ³ 25 mm2 should be > 70%· · Elderly subject 61 years and over (i.e., ³ 61) - number of seroconversions1 or significant increase in antibody titer2 > 30% - mean geometric increase > 2.0 - the proportion of subjects achieving an SRH area ³ 25 mm2 should be > 60% | — |
Countries
Italy, United Kingdom
Outcome results
None listed