NOVEL VACCINE

1 . The use of an influenza antigen preparation obtainable by the following process, in the manufacture of an intradermal flu vaccine:

(i) harvesting of virus-containing material from a culture;

(ii) clarification of the harvested material to remove non-virus material;

(iii) concentration of the harvested virus;

(iv) a further step to separate whole virus from non-virus material;

(v) splitting of the whole virus using a suitable splitting agent in a density gradient centrifugation step;

(vi) filtration to remove undesired materials;

wherein the steps are performed in that order but not necessarily consecutively.

2 . The use according to claim 1 wherein the intradermal flu vaccine is a trivalent vaccine.

3 . The use according to claim 1 or claim 2 wherein the virus is grown on embryonated hen eggs and the harvested material is allantoic fluid.

4 . The use according to any one of claims 1 to 3 wherein the clarification step is performed by centrifugation at a moderate speed.

5 . The use according to any one of claims 1 to 4 wherein the concentration step employs an adsorption method such as CaHPO 4 adsorption.

6 . The use according to any one of claims 1 to 5 wherein the further separation step (iv) is a zonal centrifugation separation using a sucrose gradient.

7 . The use according to claim 6 wherein the splitting step is performed in a further sucrose gradient, wherein the sucrose gradient contains the splitting agent.

8 . The use according to claim 7 wherein the splitting agent is sodium deoxycholate.

9 . The use according to any one of claims 1 to 8 wherein the filtration step (vi) is an ultrafiltration step which concentrates the split virus material.

10 . The use according to any one of claims 1 to 9 wherein there is at least one sterile filtration step, optionally at the end of the process.

11 . The use according to any one of claims 1 to 10 wherein an inactivation step is performed prior to the final filtration step.

12 . The use according to any one of claims 1 to 11 wherein the method comprises the further step of adjusting the concentration of one or more detergents in the vaccine composition.

13 . The use according to any one of claims 1 to 12 wherein the vaccine is provided in a dose volume of between about 0.1 and about 0.2 ml.

14 . The use according to any one of claims 1 to 13 wherein the vaccine is provided with an antigen dose of 1-7.5 μg haemagglutinin per strain of influenza present.

15 . The use according to any one of claims 1 to 14 wherein the vaccine further comprises an adjuvant such as an adjuvant comprising a combination of cholesterol, a saponin and an LPS derivative.

16 . The use of a trivalent, split influenza antigen preparation in the manufacture of a vaccine for intradermal delivery.

17 . The use according to claim 16 wherein the intradermal vaccine comprises at least one non-ionic surfactant.

18 . A pharmaceutical kit comprising an intradermal delivery device and an influenza vaccine obtainable by the following process:

(i) harvesting of virus-containing material from a culture;

(ii) clarification of the harvested material to remove non-virus material;

(iii) concentration of the harvested virus;

(iv) a further step to separate whole virus from non-virus material;

(v) splitting of the whole virus using a suitable splitting agent in a density gradient centrifugation step;

(vi) filtration to remove undesired materials;

wherein the steps are performed in that order but not necessarily consecutively.

19 . The pharmaceutical kit according to claim 18 wherein the intradermal delivery device is a short needle delivery device.