REGIMENS FOR IMMUNISATION WITH MENINGOCOCCAL CONJUGATES

Abstract

Multivalent meningococcal conjugate vaccines are administered according to a schedule in which a first dose is administered to a patient aged between 0 and 12 months, and a second dose is administered to the patient aged between 12 and 24 months.

Claims

1. A kit comprising: (a) a multivalent meningococcal capsular saccharide-carrier protein conjugate vaccine; and (b) instructions for administering the vaccine according to a schedule that includes: (a) first administering the vaccine to a patient when said patient is about 6 months of age; and (b) then administering the vaccine to the patient when said patient is about 12 months of age, wherein the multivalent meningococcal capsular saccharide-carrier protein conjugate vaccine includes capsular saccharide-carrier protein conjugates of at least meningococcal serogroups A, C, W135 and Y.

2. The kit of claim 1, wherein the carrier protein is selected from diphtheria toxoid and CRM197.

3. The kit of claim 1, wherein the multivalent meningococcal capsular saccharide-carrier protein conjugate vaccine is unadjuvanted.

4. The kit of claim 1, wherein the multivalent meningococcal capsular saccharide-carrier protein conjugate vaccine is adjuvanted.

5. The kit of claim 1, wherein the schedule includes: (a) first administering the vaccine to a patient when said patient is 6 months of age.

6. The kit of claim 1, wherein the schedule includes: (b) administering the vaccine to the patient when said patient is about 12 months of age.

7. The kit of claim 1, wherein the schedule includes: (a) first administering the vaccine to a patient when said patient is 6 months of age; and (b) then administering the vaccine to the patient when said patient is 12 months of age.

Description

MODES FOR CARRYING OUT THE INVENTION

[0096] The immunogenicity, safety, tolerability and the ability to prime for memory of a meningococcal conjugate vaccine are investigated in a multi-centre, open-label, controlled, randomized study. Infants are split into three groups to receive an unadjuvanted 4-valent conjugated A-C-W135-Y vaccine as follows, with the group 1 schedule being an embodiment of the invention: [0097] 1: first doses at about 6 months, then a second dose at about 12 months (on or after birthday) [0098] 2: single dose at about 12 months (on or after birthday) [0099] 3: dose of monovalent MenC at 12 months, then 4-valent at 18 months.

[0100] Meningococcal conjugates are administered at the same time as other routine pediatric vaccines, and blood samples for serological analysis are taken both at the time of vaccination and 1 month later:

TABLE-US-00001 Visit 1 Visit 2 Visit 3 Visit 4 Group 1 6 months 7 months 12 months 13 months B, M4, PC7, 5 B B, M4, PC7 B, 4V Group 2 6 months 7 months 12 months 13 months B, PC7, 5 B B, M4, PC7 B, 4V Group 3 12 months 13 months 18 months 19 months B, M1, PC7 B, 4V B, M4, 5 B Key: B = blood taken for serology; 5 = D-T-Pa-Hib-IPV; PC7 = 7-valent pneumococcal conjugate; 4V = MMR + V; M4 =4-valentMen-A-C-W135-Yconjugates; M1 = Men-C conjugate.

[0101] Immunogenicity is assessed by evaluating serum antibody responses by measuring bactericidal antibody titers.

[0102] For blood samples taken at the first 2 visits, the bactericidal antibody titer at visit 2, expressed as a ratio relative to visit 1, was as follows for each group:

TABLE-US-00002 A C W135 Y Group 1 1.5 11 2.8 1.8 Group 2 1.0 1 1.0 1.0 Group 3 1.0 20 1.0 1.0

[0103] It will be understood that the invention has been described by way of example only, and that modifications may be made whilst remaining within the scope and spirit of the invention.

REFERENCES

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