Abstract: Abstract of the invention The present invention relates to a multivalent Pneumococcal conjugate vaccine (PCV) composition comprising: at least 12 capsular polysaccharides selected from serotypes 1, 3, 4, 5, 6B, 7F, 9N, 9V, 15B, 14, 18C, 19A, 19F, 22F, 23F and 33F of S. pneumoniae activated with CDAP and conjugated to carrier protein selected from CRM197, pneumococcal surface protein A (PspA), pneumococcal adhesin protein (PsaA) or combination thereof and a pharmaceutically acceptable carrier, wherein the composition does not contain capsular polysaccharide from serotype 6A.
We claim:
1. A multivalent Pneumococcal conjugate vaccine (PCV) composition comprising:
a) at least 12 capsular polysaccharides selected from serotypes 1, 3, 4, 5, 6B, 7F, 9N, 9V, 15B, 14, 18C, 19A, 19F, 22F, 23F and 33F of S. pneumoniae activated with CDAP and conjugated to carrier protein selected from CRM197, pneumococcal surface protein A (PspA), pneumococcal adhesin protein (PsaA) or combination thereof and
b) a pharmaceutically acceptable carrier, wherein the composition does not contain capsular polysaccharide from serotype 6A.
2. A multivalent Pneumococcal conjugate vaccine (PCV) composition comprising:
a) at least 14 capsular polysaccharides selected from serotypes 1, 3, 4, 5, 6B, 7F, 9N, 9V, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F of S. pneumoniae activated with CDAP and conjugated to CRM197, PspA, PsaA or combination thereof and
b) a pharmaceutically acceptable carrier, wherein the composition does not contain capsular polysaccharide from serotype 6A.
3. The composition as claimed in claims 1 and 2, further comprises one or more serotypes selected from 6C, 8, 10A, 11 A, 12F, 15A, 23A, 23B and 35B of S. pneumoniae.
4. The composition as claimed in claims 1 and 2, wherein the amount of polysaccharide from each of the serotypes is 1 to 10 ug.
5. The composition as claimed in claims 1 and 2, wherein the amount of carrier protein conjugated to polysaccharide is 3 to 30 ug.
6. The composition as claimed in claim 1, wherein the single 0.5 mL dose contain 2 ug of each polysaccharide; 30-40ug CRM197 carrier protein; 0.2 to 1 mg of aluminum phosphate adjuvant; sodium chloride and buffer.
7. A 14 valent sterile liquid Pneumococcal conjugate vaccine (PCV) formulation comprising 2 ug of each capsular polysaccharides of serotypes 1, 3, 4, 5, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F, 4 ug of serotype 6B each individually conjugated to about 32 ug CRM197; 0.125 mg of elemental aluminum (0.5 mg aluminum phosphate) adjuvant; and sodium chloride and L-histidine buffer, wherein the formulation does not contain capsular polysaccharide from serotype 6A.
8. A 13 valent sterile liquid Pneumococcal conjugate vaccine (PCV) formulation comprising 2 ug of each capsular polysaccharides of serotypes 1, 3, 4, 5, 7F, 9V, 14, 18C, 19A, 19F, 22F and 33F, 4 ug of serotype 6B each individually conjugated to about 32 ug CRM197; 0.125 mg of elemental aluminum (0.5 mg aluminum phosphate) adjuvant; and sodium chloride and L-histidine buffer, wherein the formulation does not contain capsular polysaccharide from serotype 6A.
9. A 13 valent sterile liquid Pneumococcal conjugate vaccine (PCV) formulation comprising 2 ug of each capsular polysaccharides of serotypes 1, 3, 4, 5, 7F, 9V, 14, 18C, 19A, 19F, 23F and 33F, 4 ug of serotype 6B each individually conjugated to about 32 ug of CRM197; 0.125 mg of elemental aluminum (0.5 mg aluminum phosphate) adjuvant; and sodium chloride and L-histidine buffer, wherein the formulation does not contain capsular polysaccharide from serotype 6A.
10. A serotype composition for formulating a 13 valent PCV comprising;
a) conjugation of the pneumococcal capsular polysaccharides of known size from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F and 33F activated utilizing CDAP, individually to an immunogenic carrier protein CRM197,
b) diafiltration of the individual monovalent pneumococcal conjugates followed by purification using size exclusion chromatography,
c) analysis of the fractions by SEC-HPLC and pooling of fractions containing monovalent pneumococcal conjugates before filter sterilization using 0.2um filter,
d) formulation of the 13 valent PCV using 13 monovalent pneumococcal conjugates; 4.4ug for serotype 6B; 2.2ug for rest of the serotypes and Adju-Phos® adjuvant together with appropriate excipient and buffer followed by aseptic filling,
e) wherein the said 13 valent PCV does not contain capsular polysaccharide from serotype 6A.
11. A serotype composition for formulating a 14 valent PCV comprising;
a) conjugation of pneumococcal capsular polysaccharides of known size from serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F activated utilizing CDAP, individually to an immunogenic carrier protein CRM197,
b) diafiltration of the individual monovalent pneumococcal conjugates followed by purification using size exclusion chromatography,
c) analysis of the fractions by SEC-HPLC and pooling of fractions containing monovalent pneumococcal conjugates before filter sterilization using 0.2um filter and
d) formulation of the 14 valent PCV using monovalent pneumococcal conjugates; 4.4ug for serotype 6B; 2.2ug for rest of the serotypes and Adju-Phos® adjuvant together with appropriate excipient and buffer followed by aseptic filling.
| Section | Controller | Decision Date |
|---|---|---|
| # | Name | Date |
|---|---|---|
| 1 | 3140-CHE-2015-US(14)-HearingNotice-(HearingDate-11-05-2021).pdf | 2021-10-17 |
| 1 | Provisional Specification - PCV Patent-MultiV-Formulation- Form 2.pdf | 2015-06-24 |
| 2 | 3140-CHE-2015-IntimationOfGrant08-07-2021.pdf | 2021-07-08 |
| 2 | FORM 26-Biological.pdf | 2015-06-24 |
| 3 | Other Document [31-05-2016(online)].pdf | 2016-05-31 |
| 3 | 3140-CHE-2015-PatentCertificate08-07-2021.pdf | 2021-07-08 |
| 4 | Form13_Address of Service Change_31-05-2016.pdf | 2016-05-31 |
| 4 | 3140-CHE-2015-Written submissions and relevant documents [24-05-2021(online)].pdf | 2021-05-24 |
| 5 | Drawing [15-06-2016(online)].pdf | 2016-06-15 |
| 5 | 3140-CHE-2015-Correspondence to notify the Controller [07-05-2021(online)].pdf | 2021-05-07 |
| 6 | Description(Complete) [15-06-2016(online)].pdf | 2016-06-15 |
| 6 | 3140-CHE-2015-ABSTRACT [09-12-2020(online)].pdf | 2020-12-09 |
| 7 | CERTIFIED COPIES TRANSMISSION TO IB [27-06-2016(online)].pdf | 2016-06-27 |
| 7 | 3140-CHE-2015-CLAIMS [09-12-2020(online)].pdf | 2020-12-09 |
| 8 | Assignment [01-07-2016(online)].pdf | 2016-07-01 |
| 8 | 3140-CHE-2015-FER_SER_REPLY [09-12-2020(online)].pdf | 2020-12-09 |
| 9 | 3140-CHE-2015-FORM 3 [09-12-2020(online)].pdf | 2020-12-09 |
| 9 | 3140-CHE-2015-Power of Attorney-070616.pdf | 2016-07-22 |
| 10 | 3140-CHE-2015-Correspondence-PA-070616.pdf | 2016-07-22 |
| 10 | 3140-CHE-2015-OTHERS [09-12-2020(online)].pdf | 2020-12-09 |
| 11 | 3140-CHE-2015-Form 5-050716.pdf | 2016-07-27 |
| 11 | 3140-CHE-2015-Proof of Right [09-12-2020(online)].pdf | 2020-12-09 |
| 12 | 3140-CHE-2015-Correspondence-F5-COMPLETE SPECIFICATION-050716.pdf | 2016-07-27 |
| 12 | 3140-CHE-2015-FER.pdf | 2020-06-11 |
| 13 | 3140-CHE-2015--COMPLETE SPECIFICATION-050716.pdf | 2016-07-27 |
| 13 | Correspondence by Agent_Power of Attorney_12-09-2019.pdf | 2019-09-12 |
| 14 | 3140-CHE-2015-FORM 13 [09-09-2019(online)].pdf | 2019-09-09 |
| 14 | Form 3 [19-08-2016(online)].pdf | 2016-08-19 |
| 15 | 3140-CHE-2015-FORM-26 [09-09-2019(online)].pdf | 2019-09-09 |
| 15 | Form-2(Online).pdf | 2016-09-30 |
| 16 | 3140-CHE-2015-FORM 3 [06-09-2019(online)].pdf | 2019-09-06 |
| 16 | Form 3 [02-02-2017(online)].pdf | 2017-02-02 |
| 17 | Form3_After Filing_14-02-2017.pdf | 2017-02-14 |
| 17 | 3140-CHE-2015-FORM 3 [03-09-2018(online)].pdf | 2018-09-03 |
| 18 | Correspondence by Agent _Form 3_08-03-2018.pdf | 2018-03-08 |
| 18 | Form26_Power of Attorney_14-02-2017.pdf | 2017-02-14 |
| 19 | 3140-CHE-2015-FORM 3 [03-03-2018(online)].pdf | 2018-03-03 |
| 19 | Correspondence by Agent_Power of Attorney_14-02-2017.pdf | 2017-02-14 |
| 20 | Correspondence by Agent_Copy of Form18_11-05-2017.pdf | 2017-05-11 |
| 20 | Form 18 [09-05-2017(online)].pdf | 2017-05-09 |
| 21 | Correspondence by Agent_Copy of Form18_11-05-2017.pdf | 2017-05-11 |
| 21 | Form 18 [09-05-2017(online)].pdf | 2017-05-09 |
| 22 | 3140-CHE-2015-FORM 3 [03-03-2018(online)].pdf | 2018-03-03 |
| 22 | Correspondence by Agent_Power of Attorney_14-02-2017.pdf | 2017-02-14 |
| 23 | Correspondence by Agent _Form 3_08-03-2018.pdf | 2018-03-08 |
| 23 | Form26_Power of Attorney_14-02-2017.pdf | 2017-02-14 |
| 24 | Form3_After Filing_14-02-2017.pdf | 2017-02-14 |
| 24 | 3140-CHE-2015-FORM 3 [03-09-2018(online)].pdf | 2018-09-03 |
| 25 | 3140-CHE-2015-FORM 3 [06-09-2019(online)].pdf | 2019-09-06 |
| 25 | Form 3 [02-02-2017(online)].pdf | 2017-02-02 |
| 26 | 3140-CHE-2015-FORM-26 [09-09-2019(online)].pdf | 2019-09-09 |
| 26 | Form-2(Online).pdf | 2016-09-30 |
| 27 | 3140-CHE-2015-FORM 13 [09-09-2019(online)].pdf | 2019-09-09 |
| 27 | Form 3 [19-08-2016(online)].pdf | 2016-08-19 |
| 28 | 3140-CHE-2015--COMPLETE SPECIFICATION-050716.pdf | 2016-07-27 |
| 28 | Correspondence by Agent_Power of Attorney_12-09-2019.pdf | 2019-09-12 |
| 29 | 3140-CHE-2015-Correspondence-F5-COMPLETE SPECIFICATION-050716.pdf | 2016-07-27 |
| 29 | 3140-CHE-2015-FER.pdf | 2020-06-11 |
| 30 | 3140-CHE-2015-Form 5-050716.pdf | 2016-07-27 |
| 30 | 3140-CHE-2015-Proof of Right [09-12-2020(online)].pdf | 2020-12-09 |
| 31 | 3140-CHE-2015-Correspondence-PA-070616.pdf | 2016-07-22 |
| 31 | 3140-CHE-2015-OTHERS [09-12-2020(online)].pdf | 2020-12-09 |
| 32 | 3140-CHE-2015-FORM 3 [09-12-2020(online)].pdf | 2020-12-09 |
| 32 | 3140-CHE-2015-Power of Attorney-070616.pdf | 2016-07-22 |
| 33 | 3140-CHE-2015-FER_SER_REPLY [09-12-2020(online)].pdf | 2020-12-09 |
| 33 | Assignment [01-07-2016(online)].pdf | 2016-07-01 |
| 34 | 3140-CHE-2015-CLAIMS [09-12-2020(online)].pdf | 2020-12-09 |
| 34 | CERTIFIED COPIES TRANSMISSION TO IB [27-06-2016(online)].pdf | 2016-06-27 |
| 35 | 3140-CHE-2015-ABSTRACT [09-12-2020(online)].pdf | 2020-12-09 |
| 35 | Description(Complete) [15-06-2016(online)].pdf | 2016-06-15 |
| 36 | Drawing [15-06-2016(online)].pdf | 2016-06-15 |
| 36 | 3140-CHE-2015-Correspondence to notify the Controller [07-05-2021(online)].pdf | 2021-05-07 |
| 37 | Form13_Address of Service Change_31-05-2016.pdf | 2016-05-31 |
| 37 | 3140-CHE-2015-Written submissions and relevant documents [24-05-2021(online)].pdf | 2021-05-24 |
| 38 | Other Document [31-05-2016(online)].pdf | 2016-05-31 |
| 38 | 3140-CHE-2015-PatentCertificate08-07-2021.pdf | 2021-07-08 |
| 39 | FORM 26-Biological.pdf | 2015-06-24 |
| 39 | 3140-CHE-2015-IntimationOfGrant08-07-2021.pdf | 2021-07-08 |
| 40 | Provisional Specification - PCV Patent-MultiV-Formulation- Form 2.pdf | 2015-06-24 |
| 40 | 3140-CHE-2015-US(14)-HearingNotice-(HearingDate-11-05-2021).pdf | 2021-10-17 |
| 41 | 3140-CHE-2015-FORM-27 [08-05-2025(online)].pdf | 2025-05-08 |
| 1 | 2020-06-1013-50-45E_10-06-2020.pdf |