NOVEL VACCINE COMPOSITION

1 - 35 . (canceled)

36 . An influenza vaccine comprising an inactivated influenza virus preparation and an adjuvant, wherein said inactivated influenza virus preparation comprises hemagglutinin antigen (HA), 0 μg/ml to 5 μg/ml of thiomersal and at least one stabilising excipient, and wherein said adjuvant is selected from the group of: an oil in water emulsion, a non-toxic derivative of lipid A, a saponin or derivative thereof, and a combination of two or more of said adjuvants.

37 . The influenza vaccine according to claim 36 , wherein said non-toxic derivative of lipid A is 3D-MPL.

38 . The influenza vaccine according to claim 36 , wherein 3D-MPL is in the form of an emulsion having a small particle size less than 0.2 μm in diameter.

39 . The influenza vaccine according to claim 36 , wherein said said excipient comprises α-tocopherol or a derivative thereof.

40 . The influenza vaccine according to claim 36 , wherein said excipient comprises α-tocopherol succinate.

41 . The influenza vaccine according to claim 36 , wherein said excipient comprises a positively or negatively or zwitterionic charged amphiphilic molecule.

42 . The influenza vaccine according to claim 36 , wherein said excipient comprises a non-ionic amphiphilic molecule from the group of: octyl- or nonylphenoxy polyoxyethanols, polyoxyethylene sorbitan esters and polyoxyethylene ethers or esters of general formula (I):

HO(CH2CH2O) n -A-R   (I)

wherein n is 1-50, A is a bond or —C(O)—, R is C 1-50 alkyl or phenyl C 1-50 alkyl; and combinations of two or more of these.

43 . The influenza vaccine according to claim 42 , wherein said non-ionic amphiphilic molecule is selected from the group of: Triton X-45, t-octylphenoxy polyethoxyethanol (Triton X-100™), Triton X-102, Triton X-114, Triton X-165, Triton X-205, Triton X-305, Triton N-57, Triton N-101, Triton N-128, Breij 35, polyoxyethylene-9-lauryl ether (laureth 9), polyoxyethylene-9-stearyl ether (steareth 9), polyoxyethylene sorbitan ester, and polyoxyethylene sorbitan monooleate (Tween 80™).

44 . The influenza vaccine according to claim 42 , wherein said non-ionic amphiphilic molecule is selected from the group: Triton X-100™, Tween 80™, and a combination of both.

45 . The influenza vaccine according to claim 39 , wherein the a-tocopherol or derivative thereof is present at a concentration between 1 μg/ml and 10 mg/ml.

46 . The influenza vaccine according to claim 36 , wherein the α-tocopherol is present at a concentration between 1 μg/ml and 10 mg/ml.

47 . The influenza vaccine according to claim 36 , wherein said influenza virus antigen preparation is selected from the group consisting of: split virus antigen preparations, subunit antigens, chemically or otherwise inactivated whole virus and recombinantly produced haemagglutinin antigen.

48 . The influenza vaccine according to claim 36 , wherein the concentration of haemagglutinin antigen for each strain of influenza is 1-1000 μg per ml, as measured by a Single radial Immunodiffusion (SRD) assay.

49 . The influenza vaccine according to claim 36 , wherein said influenza virus antigen preparation is derived from the embryonated egg method or derived from cell culture.

50 . The influenza vaccine according to claim 36 , wherein said influenza virus antigen preparation comprises a haemagglutinin antigen that is produced recombinantly.

51 . An inactivated influenza virus preparation, comprising hemagglutinin antigen (HA), 0 μg/ml to 5 pg/ml of thiomersal, and at least one of α-tocopherol or a derivative thereof in an amount sufficient to stabilize said HA.

52 . The inactivated influenza virus preparation of claim 50 , wherein said influenza virus is selected from the group of: split virus antigen preparations, subunit antigens, chemically or otherwise inactivated whole virus, and recombinantly produced haemagglutinin antigen.

53 . The inactivated influenza virus preparation of claim 50 , wherein said preparation comprises α-tocopherol or α-tocopherol succinate.

54 . The inactivated influenza virus preparation of claim 50 , wherein the at least one of α-tocopherol or a derivative thereof is present in an amount such that the HA of said preparation remains stable for at least 6 months after said preparation is produced as determined by the presence of an amount of HA detectable by Single radial Immunodiffusion (SRD) assay.

55 . The inactivated influenza virus preparation of claim 50 , wherein the at least one of a-tocopherol or a derivative thereof further comprises at least one of a non-ionic amphiphilic molecule from the group of: octyl- or nonylphenoxy polyoxyethanols, polyoxyethylene sorbitan esters and polyoxyethylene ethers or esters of general formula (I):

HO(CH2CH2O) n -A-R   (I)

wherein n is 1-50, A is a bond or —C(O)—, R is C 1-50 alkyl or phenyl C 1-50 alkyl; and combinations of two or more of these.

56 . The inactivated influenza virus preparation of claim 55 , wherein said non-ionic amphiphilic molecule is selected from the group of: Triton X-45, t-octylphenoxy polyethoxyethanol (Triton X-100™), Triton X-102, Triton X-114, Triton X-165, Triton X-205, Triton X-305, Triton N-57, Triton N-101, Triton N-128, Breij 35, polyoxyethylene-9-lauryl ether (laureth 9), polyoxyethylene-9-stearyl ether (steareth 9), polyoxyethylene sorbitan ester, and polyoxyethylene sorbitan monooleate (Tween 80™).

57 . The inactivated influenza virus preparation of claim 55 , wherein said non-ionic amphiphilic molecule is selected from the group: Triton X-100™, Tween 80™, and a combination of both.

58 . The inactivated influenza virus preparation according to claim 50 , wherein the α-tocopherol or derivative thereof is present at a concentration between 1 pg/ml and 10 mg/ml.

59 . A vaccine comprising the inactivated influenza virus preparation of claim 50 .

60 . An influenza vaccine according to claim 58 , wherein the vaccine additionally comprises an adjuvant.