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.
Product Code: FLUVIRIN®
Pharmaceutical F
Sponsors
Chiron Vaccines 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 general 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, 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, 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. 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 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., 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 |
|---|---|
| Main Objective: To evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination 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 (CHMP/BWP/214/96).;Secondary Objective: To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUVIRN® Surface Antigen in non-elderly adult and elderly subjects.;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 area ratio (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 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