IP Library › Patent Application 13271810
Patent Application
App. No. 13/271,810

KITS FOR ONE-DOSE INTRADERMAL DELIVERY FOR NON-LIVE TRIVALENT INFLUENZA VACCINE

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Quick Facts
Patent No.
US None
App. No.
13/271,810
Abstract

The invention relates to a pharmaceutical kit for one-dose influenza vaccine for intradermal delivery of a trivalent, non-live influenza antigen preparation, particularly a split influenza preparation.

Claims (28)

1 . A pharmaceutical kit comprising:

(i) a short needle intradermal delivery device adapted to limit administration to a location between 1.0 mm and 2.0 mm below a surface of human skin; and

(ii) a trivalent, split or subunit influenza vaccine antigen preparation.

2 . The pharmaceutical kit according to claim 1 , wherein the vaccine antigen preparation is a trivalent, split influenza vaccine antigen preparation.

3 . The pharmaceutical kit according to claim 1 , wherein the vaccine antigen preparation is a trivalent, subunit influenza vaccine antigen preparation.

4 . The pharmaceutical kit according to claim 2 , wherein the volume of the vaccine antigen preparation is between about 0.05 and about 0.2 ml.

5 . The pharmaceutical kit according to claim 2 , wherein the intradermal delivery device is supplied already filled with the vaccine antigen preparation.

6 . The pharmaceutical kit according to claim 3 , wherein the volume of the vaccine antigen preparation is between about 0.05 and about 0.2 ml.

7 . The pharmaceutical kit according to claim 3 , wherein the intradermal delivery device is supplied already filled with the vaccine antigen preparation.

8 . A pharmaceutical kit comprising:

(i) a short needle intradermal delivery device adapted to limit administration to a location between 1.0 mm and 2.0 mm below a surface of human skin; and

(ii) a trivalent, split or subunit influenza vaccine antigen preparation, wherein the protective immune response resulting from administration of said vaccine antigen preparation to a human population of at least 18 years of age meets at least one criterion chosen from the group of: (1) a protection rate of >70% in adults of 18-60 years of age or of >60% in elderly people of above 60 years of age; (2) a seroconversion rate of >40% in adults of 18-60 years of age or of >30% in elderly people of above 60 years of age; or (3) a conversion factor of >2.5 HI titres in adults of 18-60 years of age or of >2.0 HI titres in elderly people of above 60 years of age, for each influenza strain.

9 . The pharmaceutical kit according to claim 8 comprising:

(i) a short needle intradermal delivery device adapted to limit administration to a location between 1.0 mm and 2.0 mm below a surface of human skin; and

(ii) a trivalent, split or subunit influenza vaccine antigen preparation, wherein the protective immune response resulting from administration of said vaccine antigen preparation to a human population of at least 18 years of age meets at least two criteria from the group of: (1) a protection rate of >70% in adults of 18-60 years of age or of >60% in elderly people of above 60 years of age; (2) a seroconversion rate of >40% in adults of 18-60 years of age or of >30% in elderly people of above 60 years of age; or (3) a conversion factor of >2.5 HI titres in adults of 18-60 years of age or of >2.0 HI titres in elderly people of above 60 years of age, for each influenza strain.

10 . The pharmaceutical kit according to claim 8 comprising:

(i) a short needle intradermal delivery device adapted to limit administration to a location between 1.0 mm and 2.0 mm below a surface of human skin; and

(ii) a trivalent, split or subunit influenza vaccine antigen preparation, wherein the protective immune response resulting from administration of said vaccine antigen preparation to a human population of at least 18 years of age meets three criteria from the group of: (1) a protection rate of >70% in adults of 18-60 years of age or of >60% in elderly people of above 60 years of age; (2) a seroconversion rate of >40% in adults of 18-60 years of age or of >30% in elderly people of above 60 years of age; or (3) a conversion factor of >2.5 HI titres in adults of 18-60 years of age or of >2.0 HI titres in elderly people of above 60 years of age, for each influenza strain.

11 . The pharmaceutical kit according to claim 8 , wherein a volume of the vaccine antigen preparation is between about 0.05 and about 0.2 ml.

12 . The pharmaceutical kit according to claim 8 , wherein the intradermal delivery device is supplied already filled with the vaccine antigen preparation.

13 . The pharmaceutical kit according to claim 9 , wherein a volume of the vaccine antigen preparation is between about 0.05 and about 0.2 ml.

14 . The pharmaceutical kit according to claim 9 , wherein the intradermal delivery device is supplied already filled with the vaccine antigen preparation.

15 . The pharmaceutical kit according to claim 10 , wherein a volume of the vaccine antigen preparation is between about 0.05 and about 0.2 ml.

16 . The pharmaceutical kit according to claim 10 , wherein the intradermal delivery device is supplied already filled with the vaccine antigen preparation.

17 . A pharmaceutical kit comprising:

(i) a short needle intradermal delivery device adapted to limit administration to a location between 1.0 mm and 2.0 mm below a surface of human skin; and

(ii) a trivalent, split influenza vaccine antigen preparation

wherein the intradermal delivery device is supplied already filled with between about 0.05 and about 0.2 ml of the vaccine antigen preparation.