Prophylaxis of Influenza
Conditions
Interventions
Trade Name: FLUVIRIN® Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur.
Product Name: FLUVIRIN® Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur.
Pharmace
Sponsors
Novartis Vaccines and Diagnostics Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrollment into this study are male and female 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 good health as determined by: · medical history · physical examination · clinical judgment of the investigator Informed consent must be obtained for all the subjects before enrollment in the study. 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: Individuals are not to be enrolled into the study if: 1. they 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. they are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, thiomersal, neomycin or polymyxin, or any other component of the vaccine; 3. they have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine; 4. 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 in: · receipt of immunosuppressive therapy (oral or parenteral corticosteroids, except topical or inhaled steroids 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. they have a known or suspected history of drug or alcohol abuse; 6. they 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 lactating, or who refuse to undergo a pregnancy test, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days); 8. within the past 12 months, they have: · received more than one injection of influenza vaccine; 9. within the past 6 months, they have: · had laboratory confirmed influenza disease; · received influenza vaccine; 10. within the past 4 weeks they have received: · another vaccine; · any investigational agent; 11. within the past 7 days, they have experienced: · any acute disease; · infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable); 12. they have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days 13 within the past 3 days they have experienced: · fever (i.e., axillary body temperature = 38°C); 14. they are taking part in another clinical study; 15. they have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate safety of the administration of a single intramuscular (IM) injection of FLUVIRIN® in non-elderly adult and elderly subjects.;Main Objective: To evaluate the antibody response to each influenza vaccine antigen, as measured by hemagglutination inhibition (HI) at 21 days post-immunization 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).; Primary end point(s): The measures of immunogenicity for each antigen are: · the geometric mean titer (GMT) on Day 0 and Day 21 · the Day 21/Day 0 geometric mean titer ratios (GMR) · the percentage of subjects achieving seroconversion* or significant increase in antibody titer** · the percentage of subjects achieving an HI titer = 40 on Day 0 and on Day 21 * Seroconversion is defined as negative pre-vaccination serum ( 40% - mean geometric increase > 2.5 - the proportion of subjects achieving an HI titer =40, should be > 70% • Elderly subjects 61 years and older (i.e., = 61) - number of seroconversions* or significant increase in antibody titer** > 30% - mean geometric increase > 2.0 - the proportion of subjects achieving an HI titer =40 should be > 60% * Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination titer =40. ** Significant increase in antibody titer is defined as at least a fourfold increase in HI titer from non-negative pre-vaccination serum (=10). | — |
Countries
United Kingdom
Outcome results
None listed