no medical condition
Conditions
Sponsors
Chiron Behring 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 2. have given the written informed consent prior to the study entry and after the nature of the study has been explained 3. available for all the visits scheduled in the study 4. in good health as determined by: - medical history - physical examination - clinical judgment of the investigator Informed consent must be obtained from 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: Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled: 1. They have any serious chronic disease such as: a. history of cancer (leukemia, lymphomas, neoplasm) b. congestive heart failure c. advanced arteriosclerotic disease d. COPD requiring oxygen therapy e. autoimmune disease f. insulin dependent diabetes mellitus g. acute or progressive hepatic disease h. acute or progressive renal failure 2. They have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component. 3. They have a known or suspected impairment/alteration of immune function resulting for example from: a. receipt of immunosuppressive therapy (any systemic cortical steroid or cancer chemotherapy) within the last 2 months 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. They have a known or suspected history of drug or alcohol abuse. 5. They have a bleeding diathesis or any condition that may be associated with a prolonged bleeding time. 6. Women who are pregnant or who could become pregnant during the study but are not willing to practice acceptable contraception for the duration of the study (21 days). 7. Within the last 6 months they have a) had laboratory confirmed influenza disease b) have been vaccinated against influenza 8. Within the last 4 weeks they have received a) another vaccine b) any investigational agent 9. They have experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 14 days. 10. They have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the last 14 days. 11. They have experienced fever (i.e. body temperature ³ 38.0°C) within the past 3 days. 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 objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity Objectives Immunogenicity with respect to specific antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21, i.e., 21 days after vaccination, 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: Safety Objectives To demonstrate the safety and tolerability of a single IM dose of the split influenza vaccine (using solicited local and systemic reactions and adverse event reporting).;Primary end point(s): Immunogenicity with respect to specific antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21, i.e., 21 days after vaccination. Safety measurements: Subjects will be observed in the clinic for 30 minutes after vaccination for possible immediate hypersensitivity reactions. Local and systemic reactions occurring within 3 days (Days 0-3) after vaccination will be collected in a subject’s diary (Local reactions: pain at the injection site, erythema, ecchymosis, swelling and induration. Systemic reactions: fever, chills/shivering, malaise, headache, myalgia, arthralgia, sweating and fatigue). Serious adverse events and/or adverse events necessitating a physician’s visit and/or resulting in subject withdrawal from study will be collected throughout the study. All other adverse events will be collected up to 3 days after vaccination. | — |
Countries
Germany
Outcome results
None listed