Prophylaxis of influenza
Conditions
Interventions
Trade Name: FLUVIRIN® Surface Antigen, Inactivated Influenza Vaccine
Product Name: FLUVIRIN® Surface Antigen, Inactivated Influenza Vaccine
Pharmaceutical Form: Suspension for injection
Other descript
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, and able to give the 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 (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 complicated 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 eggs, 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 (any parenteral or oral cortical steroid or cancer chemotherapy/radiotherapy) · receipt of immunostimulants · receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months · suspected or known HIV infection or HIV-related disease 5. they have a bleeding diathesis or conditions associated with prolonged bleeding time; 6. 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); 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. 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) 11. within the past 3 days they have experienced: · fever (i.e., axillary temperature = 38°C); 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 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 (CPMP/BWP/214/96).;Secondary Objective: To evaluate safety of administration of a single intramuscular (IM) injection of FLUVIRIN® 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 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 titre =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 titre =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