A randomized, observer-blind, dose-ranging, single-centre, study to evaluate the safety, tolerability and immunogenicity of adjuvanted and non-adjuvanted influenza A/Hong Kong/1073/99 (H9N2) vaccines, containing four ascending concentrations of H9 haemagglutinin, in healthy, immunologically-naïve, adult subjects

INTERVENTION: Product Name: Whole Virion A/HongKong/1073/99 (H9N2) vaccine Product Code: WV Pharmaceutical Form: Solution for injection Other descriptive name: H9 haemagglutinin antigen Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 1.7‐ Product Name: Whole Virion A/HongKong/1073/99 (H9N2) vaccine Product Code: WV Pharmaceutical Form: Solution for injection Other descriptive name: H9 haemagglutinin antigen Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 5‐ Product Name: Whole Virion A/HongKong/1073/99 (H9N2) vaccine Product Code: WV Pharmaceutical Form: Solution for injection Other descriptive name: H9 haemagglutinin antigen Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 15‐ Product Name: Whole Virion A/HongKong/1073/99 (H9N2) vaccine Product Code: WV Pharmaceutical Form: Solution for injection Other descriptive name: H9 haemagglutinin antigen Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 45‐ Product Name: Whole Virion A/HongKong/1073/99 (H9N2) vaccine Pharmaceutical Form: Solution for injection Other descriptive name: H9 haemagglutinin antigen Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 5‐ Product Name: Whole Virion A/HongKong/1073/99 (H9N2) vaccine Pharmaceutical Form: Solution for injection Other descriptive name: H9 haemagglutinin antigen Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 15‐ Product Name: Aluminium hydroxide adjuvanted Whole Virion A/HongKong/1073/99 (H9N2) vaccine Pharmaceutical Form: Solution for injection Other descriptive name: H9 haemagglutinin antigen Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 1.7‐ Product Name: Aluminium hydroxide adjuvanted Whole Virion A/HongKong/1073/99 (H9N2) vaccine Pharmaceutical Form: Solution for injection Other descriptive name: H9 haemagglutinin antigen Co CONDITION: Vaccine study to assess the safety and immunogenicity of whole virus, alum‐adjuvanted whole virus and virosomal A/HongKong/1073/99 (H9N2) vaccine in healthy adult volunteers PRIMARY OUTCOME: Main Objective: To evaluate the immunogenicity of the following formulations of A/HongKong/1073/99 (H9N2) vaccine: ; a) Non‐adjuvanted whole virion (WV) vaccine by intramuscular and intradermal administration; b) alum‐adjuvanted whole virion (WV) vaccine by intramuscular injection; c) virosomal vaccine by intramuscular injection; ; Primary end point(s): The primary endpoint of the study is to assess each of the vaccine types with respect to the Committee for Human Medicinal Products (CPMP) licensing criteria for epidemic annual influenza vaccines. Secondary Objective: To determine the haemagglutinin (HA) antigenic content of influenza A/HongKong/1073/99 (H9N2) Whole virion vaccines required to produce a 'protective' antibody response in immunologically naive adult human populations.; To identify whether one or two doses of vaccine are required to satisfy the licensing criteria.; To examine the short term reactogenicity of the selected vaccines.; To evaluate vaccine type and dose interactions. INCLUSION CRITERIA: a) Mentally competent adults, who have signed an informed consent form after having recieved a detailed explanation of the study protocol. b) Male or female subjects older than 18 and younger than 60 years who are either healthy or have a stable medical condition. c) Able to understand and comply with all study procedures and to complete study diaries. d) Individuals who can be contacted throughout the study and are available for all study visits. e) Females should either be using secure contraceptive precautions, be surgically sterilised or post‐menopausal( defined as at least two years since the last menstrual period). 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