No medical condition, healthy volunteers will be recruited into clinical trial for annual approval of influenza vaccine with the new strain composition accordng WHO and EMEA recommendation and CPMP criteria (CPMP/BWP/214/96)
Conditions
Interventions
Trade Name: Begrivac
Product Name: Begrivac
Product Code: V44
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza A/Brisbane/59/2007 (H1N1)-like virus/15µg HA/0.5 mL dose
O
Sponsors
Novartis Vaccines and Diagnostics GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrollment into this study are male and female adults who are 1. = 18 years of age, mentally competent, willing and able to give informed consent prior to study entry 2. available for all the visits scheduled in the study and able to comply with all study requirements 3. in good health as determined by: - medical history - physical examination - clinical judgment of the investigator Written informed consent must be obtained from all the subjects before enrollment in the study after the nature of the study has been explained. 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: Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled: 1. They Have any serious (in the judgment of the investigator) disease, 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 a history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein neomycin or polymyxin). 3. 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: a. receipt of immunosuppressive therapy (any parental or oral cortical steroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; b. Receipt of immunostimulants, c. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study, d. Suspected or known HIV infection or HIV-related disease. 4. Known or suspected history of drug or alcohol abuse. 5. 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; 6. Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days). 7. Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months 8. Within the past 4 weeks they have received: - another vaccine - any investigational agent; 9. Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days. 10. They have experienced fever (i.e., axillary temperature = 38°C) within the last 3 days 11. Simultaneous participation in another clinical study. 12. Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives. 13. Severely obese with Body Mass Index (BMI) > 35 14. Site personnel involved in evaluation of safety and their immediate relatives are excluded from participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity Objectives To evaluate the antibody response to each influenza vaccine antigen, as measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21, i.e., 21 days after vaccination 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). Antibodies may be additionally quantified using the SRH test for confirmation purposes. (Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. CPMP/BWP/214/96: 12 March 1997).” Safety Objectives To evaluate safety of a single IM (intramuscular) dose of the split influenza vaccine Begrivac® 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). ;Secondary Objective: ;Primary end point(s): MEASURES OF IMMUNOGENICITY: Influenza antibody levels in serum measured by HI test on Days 0 and 21. Separately in each age group the following measures will be investigated: First, for each visit the number and proportion of subjects with a titre of antibodies of at least 40 (as measured by HI test) and the geometric means of titres (GMTs) will be determined. Second, the number and percentage of subjects with seroconversion or significant increse of titer as well as the mean geometric increase (GMT ratio) will be calcualted from these data. MEASURES OF SAFETY: Incidences of local reactions (Days 0 to 3) including ecchymosis, erythema, induration, swelling and pain at the injection site summarized by maximal severity and by age group. Incidences of systemic reactions (Days 0 to 3) including chills/shivering, malaise, myalgia, arthralgia, headache, sweatinf, fatigue and fever summarized by maximal severity and by age group. Incidences of adverse events (including local and systemic rections with a duration | — |
Countries
Germany
Outcome results
None listed