Publication of clinical trial results

The information given below and the relevant links to the clinical data fulfil the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO). They supplement the information published in association with the Swiss marketing authorisation for the medicinal product.

VAXNEUVANCE®

Pneumococcal polysaccharide conjugate vaccine (15 valent, adsorbed). Suspension for injection.

1 dose (0.5 ml) contains:

  • Pneumococcal polysaccharide serotype 11,2 2.0 micrograms
  • Pneumococcal polysaccharide serotype 31,2 2.0 micrograms
  • Pneumococcal polysaccharide serotype 41,2 2.0 micrograms
  • Pneumococcal polysaccharide serotype 51,2 2.0 micrograms
  • Pneumococcal polysaccharide serotype 6A1,2 2.0 micrograms
  • Pneumococcal polysaccharide serotype 6B1,2 4.0 micrograms
  • Pneumococcal polysaccharide serotype 7F1,2 2.0 micrograms
  • Pneumococcal polysaccharide serotype 9V1,2 2.0 micrograms
  • Pneumococcal polysaccharide serotype 141,2 2.0 micrograms
  • Pneumococcal polysaccharide serotype 18C1,2 2.0 micrograms
  • Pneumococcal polysaccharide serotype 19A1,2 2.0 micrograms
  • Pneumococcal polysaccharide serotype 19F1,2 2.0 micrograms
  • Pneumococcal polysaccharide serotype 22F1,2 2.0 micrograms
  • Pneumococcal polysaccharide serotype 23F1,2 2.0 micrograms
  • Pneumococcal polysaccharide serotype 33F 1,22.0 micrograms

1 Conjugated to CRM197 carrier protein. CRM197 is a non-toxic mutant of diphtheria toxin (from Corynebacterium diphtheriae C7) and was recombinantly expressed in Pseudomonas fluorescens.
2 Adsorbed to aluminum phosphate adjuvant.

1 dose (0.5 ml) contains 125 micrograms of aluminum (Al3+) and approximately 30 micrograms of CRM197 carrier protein.

Authorisation number: 68752

Date of Marketing Authorisation: 14-Feb-2023


Clinical Trials

Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE) – ClinicalTrials.gov
NCT03950622

Publication:
Platt HL, Cardona JF, Haranaka M, Schwartz HI, Narejos Perez S, Dowell A, Chang CJ, Dagan R, Tamms GM, Sterling T, Morgan L, Shi Y, Pedley A, Musey LK, Buchwald UK. A phase 3 trial of safety, tolerability, and immunogenicity of V114, 15-valent pneumococcal conjugate vaccine, compared with 13-valent pneumococcal conjugate vaccine in adults 50 years of age and older (PNEU-AGE). Vaccine. 2022 Jan 3;40(1):162-172. doi: 10.1016/j.vaccine.2021.08.049. Epub 2021 Sep 8. PMID: 34507861.

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH) – ClinicalTrials.gov
NCT03480763

Publication:
Song JY, Chang CJ, Andrews C, Diez-Domingo J, Oh MD, Dagan R, Hartzel J, Pedley A, Li J, Sterling T, Tamms G, Chiarappa JA, Lutkiewicz J, Musey L, Tu Y, Buchwald UK; V114-016 (PNEU-PATH) study group. Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged ≥50 years: A randomized phase III trial (PNEU-PATH). Vaccine. 2021 Oct 15;39(43):6422-6436. doi: 10.1016/j.vaccine.2021.08.038. Epub 2021 Sep 4. PMID: 34489128.

Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007) – ClinicalTrials.gov
NCT02573181

Publication:
Peterson JT, Stacey HL, MacNair JE, Li J, Hartzel JS, Sterling TM, Benner P, Tamms GM, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults ≥65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Hum Vaccin Immunother. 2019;15(3):540-548. doi: 10.1080/21645515.2018.1532250. Epub 2018 Nov 14. PMID: 30427749; PMCID: PMC6605723.

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU) – ClinicalTrials.gov
NCT03615482

Publication:
Severance R, Schwartz H, Dagan R, Connor L, Li J, Pedley A, Hartzel J, Sterling TM, Nolan KM, Tamms GM, Musey LK, Buchwald UK. Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, administered concomitantly with influenza vaccine in healthy adults aged ≥50 years: a randomized phase 3 trial (PNEU-FLU). Hum Vaccin Immunother. 2022 Dec 31;18(1):1-14. doi: 10.1080/21645515.2021.1976581. Epub 2021 Nov 2. PMID: 34726574; PMCID: PMC8920144.


Pediatric Extension

A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Catch up Vaccination Regimens of V114 in Healthy Infants, Children, and Adolescents (PNEU-PLAN)
NCT03885934

Publication:
Banniettis N, Wysocki J, Szenborn L, Phongsamart W, Pitisuttithum P, Ramet M, Richmond P, Shi Y, Dagan R, Good L, Papa M, Lupinacci R, McFetridge R, Tamms G, Churchill C, Musey L, Bickham K; V114-024 PNEU-PLAN study group. A phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of catch-up vaccination regimens of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants, children, and adolescents (PNEU-PLAN). Vaccine. 2022 Oct 19;40(44):6315-6325. doi: 10.1016/j.vaccine.2022.09.003. Epub 2022 Sep 21.

A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (PNEU-PED-EU-1)
NCT04031846

Publication:
Martinon-Torres F, Wysocki J, Szenborn L, Carmona-Martinez A, Poder A, Dagan R, Richmond P, Gilbert C, Trudel MC, Flores S, Lupinacci R, McFetridge R, Wiedmann RT, Chen Q, Gerrits H, Banniettis N, Musey L, Bickham K, Kaminski J; V114-025 PNEU-PED-EU-1 study group. A Phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V114 compared with PCV13 in healthy infants (PNEU-PED-EU-1). Vaccine. 2023 May 16;41(21):3387-3398. doi: 10.1016/j.vaccine.2023.04.036. Epub 2023 Apr 25. PMID: 37105892

A phase 3, multicenter, randomized, double-blind study to evaluate the interchangeability of V114, a 15-valent pneumococcal conjugate vaccine, and PCV13 with respect to safety, tolerability, and immunogenicity in healthy infants (PNEU-DIRECTION)
NCT03620162

Publication:
Bili A, Dobson S, Quinones J, Phongsamart W, Oberdorfer P, Kosalaraksa P, Dagan R, Richmond P, Wilck M, Vallejos W, Nunn C, McFetridge R, Tamms G, Fu R, Lupinacci R, Musey L, Banniettis N, Bickham K; V114-027 PNEU-DIRECTION study group. A phase 3, multicenter, randomized, double-blind study to evaluate the interchangeability of V114, a 15-valent pneumococcal conjugate vaccine, and PCV13 with respect to safety, tolerability, and immunogenicity in healthy infants (PNEU-DIRECTION). Vaccine. 2023 Jan 16;41(3):657-665. doi: 10.1016/j.vaccine.2022.10.072. Epub 2022 Dec 13. PMID: 36522265

A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4 dose Regimen of V114 in Healthy Infants (PNEU-PED)
NCT03893448

Publication:
Lupinacci R, Rupp R, Wittawatmongkol O, Jones J, Quinones J, Ulukol B, Dagan R, Richmond P, Stek JE, Romero L, Koseoglu S, Tamms G, McFetridge R, Li J, Cheon K, Musey L, Banniettis N, Bickham K; V114-029 PNEU-PED study group. A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED). Vaccine. 2023 Jan 27;41(5):1142-1152. doi: 10.1016/j.vaccine.2022.12.054. Epub 2023 Jan 6. PMID: 36621410

A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)
NCT03692871

Publication:
Banniettis N, Horn M, Sadarangani M, Patel SM, Greenberg D, Oberdorfer P, Klein NP, Rupp R, Dagan R, Richmond P, Lumley J, Zhou W, Shi Y, Tamms G, Feemster K, Lupinacci R, Musey L, Bickham K; V114-031 (PNEU-LINK) study group. Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study. Pediatrics. 2023 Jul 1;152(1):e2022060428. doi: 10.1542/peds.2022-060428. PMID: 37309607

CH-PVC-00033, 03/2024