No medical condition
Conditions
Interventions
Product Name: Optaflu
Product Code: V58
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza A/Solomon Islands/3/2006 (H1N1)-like virus/15µg HA/0.5mL dose
Other descriptive
Sponsors
Novartis Vaccines and Diagnostics GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 4. 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: 1. Any serious chronic or acute disease such as: a. Cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin cancer and non-metastatic prostate cancer not presently treated with chemotherapy b. Congestive heart failure c. Advanced arteriosclerotic disease d. Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy and/or acute exacerbation of a COPD within the last 14 days. e. Autoimmune disease (including rheumatoid arthritis), if under immunosuppressive therapy (see below) f. Insulin dependent diabetes mellitus g. Acute or progressive hepatic disease h. Acute or progressive renal disease i. Severe neurological or psychiatric disorder 2. 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 (chronic therapy with immunosuppressive drugs, any parenteral or oral corticosteroid (substitution dose in case of absence of suprarenal function allowed) or cancer chemotherapy/radiotherapy) 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. Known or suspected history of drug or alcohol abuse. 5. Bleeding diathesis or receive anticoagulants of the coumarin type. 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. Immunization with any other vaccine and/or any investigational vaccine four weeks prior to study start 9. Any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days. 10. Fever (i.e. body temperature = 38.0°C) within the past 3 days prior to study entry. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity Objectives To evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21, i.e., 21 days after immunization in non-elderly and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccine (CPMP/BWP/214/96). Safety Objectives Safety Objectives To evaluate safety of a single IM (intramuscular) dose of the cell-derived influenza subunit vaccine (Optaflu) in non-elderly and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccine (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. Any HI result <10 (undetectable) shall be expressed as 5 for purposes of calculation. 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 increase of titer as well as the mean geometric increase (GMT ratio) will be calculated 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, sweating, fatigue and fever summarized by maximal severity and by age group. Incidences of adverse events (including local and systemic reactions with a duration beyond Day 3 post immunization) between Day 0 and the study termination visit Day 21 (± | — |
Countries
Germany
Outcome results
None listed