A Phase III, multicenter, uncontrolled, open-label study to evaluate safety and immunogenicity of a single intramuscular dose of a trivalent subunit influenza vaccine produced in mammalian cell culture (Optaflu), using the strain composition 2007/2008, when administered to adult and elderly subjects

INTERVENTION: 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 name: Influenza A/Wisconsin/67/2005 (H3N2)‐like virus/15µg HA/0.5mL dose Other descriptive name: Influenza B/Malaysia/2506/2004 ‐ like virus/15µg HA/0.5mL dose CONDITION: No medical condition; healthy volunteers will be recruited into clinical trial for annual approval of Influenza vaccine with new strain composition according to WHO and EMEA recommendation and CPMP criteria (Note for Guidance on Harmonisation of Requirements for Influenza Vaccines, 12 March 1997, CPMP/BWP/214/96), Influenza vaccine for prevention of Influenza 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 PRIMARY OUTCOME: 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).; 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 (±1) summarized by each age group and by preferred term and system organ class (SOC). Secondary Objective: