Veröffentlichung von Ergebnissen klinischer Studien

Die nachfolgenden Informationen und die entsprechenden Links zu den klinischen Daten erfüllen die Anforderungen der Artikel 71-73 der Heilmittelverordnung (HMV). Sie ergänzen die Informationen, die im Zusammenhang mit der schweizerischen Zulassung des Arzneimittels veröffentlicht wurden.

VAXNEUVANCE®

Pneumokokken-Polysaccharid-Konjugatimpfstoff (15-valent, adsorbiert). Suspension zur Injektion.

1 Dosis (0,5 ml) enthält:

  • Pneumokokken-Polysaccharid Serotyp 11,2 2,0 Mikrogramm
  • Pneumokokken-Polysaccharid Serotyp 31,2 2,0 Mikrogramm
  • Pneumokokken-Polysaccharid Serotyp 41,2 2,0 Mikrogramm
  • Pneumokokken-Polysaccharid – Serotyp 51,2 2,0 Mikrogramm
  • Pneumokokken-Polysaccharid Serotyp 6A1,2 2,0 Mikrogramm
  • Pneumokokken-Polysaccharid Serotyp 6B1,2 4,0 Mikrogramm
  • Pneumokokken-Polysaccharid Serotyp 7F1,2 2,0 Mikrogramm
  • Pneumokokken-Polysaccharid Serotyp 9V1,2 2,0 Mikrogramm
  • Pneumokokken-Polysaccharid Serotyp 141,2 2,0 Mikrogramm
  • Pneumokokken-Polysaccharid Serotyp 18C1,2 2,0 Mikrogramm
  • Pneumokokken-Polysaccharid Serotyp 19A1,2 2,0 Mikrogramm
  • Pneumokokken-Polysaccharid Serotyp 19F1,2 2,0 Mikrogramm
  • Pneumokokken-Polysaccharid Serotyp 22F1,2 2,0 Mikrogramm
  • Pneumokokken-Polysaccharid Serotyp 23F1,2 2,0 Mikrogramm
  • Pneumokokken-Polysaccharid Serotyp 33F1,2 2,0 Mikrogramm

1 Konjugiert an CRM197-Trägerprotein. CRM197 ist eine nicht-toxische Mutante des Diphtherie-Toxins (aus Corynebacterium diphtheriae C7) und wurde rekombinant exprimiert in Pseudomonas fluorescens.
2 Adsorbiert an Aluminiumphosphat-Adjuvans.

1 Dosis (0,5 ml) enthält 125 Mikrogramm Aluminium (Al3+) und etwa 30 Mikrogramm CRM197-Trägerprotein.

Swissmedic Zulassungsnummer: 68752

Swissmedic Zulassungsdatum: 14. Februar 2023


Klinische Studien

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.


Pädiatrische Erweiterung

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