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.

CAPVAXIVE®

Pneumokokken-Polysaccharid-Konjugatimpfstoff (21-valent) zur Injektion.

1 Dosis (0,5 ml) enthält:

  • Pneumokokken-Polysaccharid-Serotyp 31 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 6A1 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 7F1 4 µg
  • Pneumokokken-Polysaccharid Serotyp 81 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 9N1 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 10A1 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 11A1 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 12F1 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 15A1 4 µg
  • Pneumokokken-Polysaccharid von deOAc15B (de-O-acetylierter Serotyp 15B)1 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 16F1 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 17F1 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 19A1 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 20A1 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 22F1 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 23A1 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 23B1 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 24F1 4 µg
  • Pneumokokken-Polysaccharid Serotyp 311 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 33F1 4 µg
  • Pneumokokken-Polysaccharid-Serotyp 35B1 4 µg

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.
1 Dosis (0,5 ml) enthält etwa 65 μg CRM197 Trägerprotein.

Swissmedic Zulassungsnummer: 69781

Swissmedic Zulassungsdatum: 23. September 2025


Klinische Studien

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3) – ClinicalTrials.gov

NCT05425732

Publication:

Platt HL, Bruno C, Buntinx E, Pelayo E, Garcia-Huidobro D, Barranco-Santana EA, Sjoberg F, Song JY, Grijalva CG, Orenstein WA, Morgan L, Fernsler D, Xu W, Waleed M, Li J, Buchwald UK; STRIDE-3 Study Group. Safety, tolerability, and immunogenicity of an adult pneumococcal conjugate vaccine, V116 (STRIDE-3): a randomised, double-blind, active comparator controlled, international phase 3 trial. Lancet Infect Dis. 2024 Oct;24(10):1141-1150. doi: 10.1016/S1473-3099(24)00344-X. Epub 2024 Jul 1.

A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4) – ClinicalTrials.gov

NCT05464420

Publication:

Scott P, Ukkonen B, Caraco Y, Perez SN, Alpizar SA, Cardona JF, Greenberg D, Grijalva CG, Orenstein W, Wiedmann RT, Fernsler D, Cheon K, Li J, Platt HL. A phase 3, randomized trial to evaluate lot-to-lot consistency of V116, an adult-specific pneumococcal conjugate vaccine (STRIDE-4). Med. 2025 Jun 18:100748. doi: 10.1016/j.medj.2025.100748. PMID: 40543503

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)- ClinicalTrials.gov

NCT05526716

Publication:

Tosin Omole, Aaron S Weinberg, Masoud Azizad, David Greenberg, Carlos G Grijalva, Walter A Orenstein, Danielle Euler, Doreen Fernsler, Jun Park, Jianing Li, Heather L Platt; STRIDE-5 study group; PMID: 40714528 DOI: 10.1016/j.vaccine.2025.127514

A phase 3 randomized, double-blind clinical study to evaluate the safety and immunogenicity of V116 when administered concomitantly with influenza vaccine in adults 50 years of age or older (V116-006) – ClinicalTrials.gov

NCT05420961

Publication:

Scott P, Haranaka M, Choi JH, Stacey H, Dionne M, Greenberg D, Grijalva CG, Orenstein WA, Fernsler D, Gallagher N, Zeng T, Li J, Platt HL; STRIDE-6 Study Group. A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older (STRIDE-6). Clin Infect Dis. 2024 Dec 17;79(6):1366-1374. doi: 10.1093/cid/ciae383.

Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7) – ClinicalTrials.gov

NCT05393037

Publication:

Pathirana J, Ramgopal M, Martin C, Lombaard JJ, Chahin C, Launay O, Ratanasuwan W, Greenberg D, Grijalva CG, Orenstein WA, Shenkerman A, Hall L, Fernsler D, Kim Y, Li J, Platt HL; STRIDE-7 Study Group. Safety, tolerability, and immunogenicity of an adult-specific pneumococcal conjugate vaccine, V116, in people living with HIV (STRIDE-7): a two-part, parallel-group, randomised, active comparator-controlled, international, phase 3 trial. Lancet HIV. 2025 Oct;12(10):e679-e690. doi: 10.1016/S2352-3018(25)00165-1. Epub 2025 Sep 12.

Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008) (STRIDE-8) – ClinicalTrials.gov

NCT05696080

Publication: not published

Poster: P-45. A Phase 3, Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Investigational Adult-Specific Pneumococcal Conjugate Vaccine, in Pneumococcal Vaccine-Naïve Adults 18–64 Years of Age with Increased Risk for Pneumococcal Disease | Open Forum Infectious Diseases | Oxford Academic

Paul Scott, MD, Jayani Pathirana, MBBS, Akira Kato, MD, Richard Tytus, BSc Phm, MD, Carlos M Perez, MD, Nigel Leslie Gilchrist, MD, Hidemi Kanou, MD, Kwang Ha Yoo, MD, Grzegorz Kania, MD, Michael Nissen, MD, Michael Livingston, MD, Amy Falk Russell, MS, Doreen Fernsler, BS, Muhammad Waleed, PhD, Jianing Li, PhD, Ulrike K Buchwald, MD, Heather L Platt, MD

Author Notes

Open Forum Infectious Diseases, Volume 12, Issue Supplement_1, February 2025, ofae631.252, https://doi.org/10.1093/ofid/ofae631.252

A Phase 3 Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Vaccine, Compared with PPSV23, in Adults ≥50 Years of Age (STRIDE-10)

NCT05569954

Publication:

Jotterand V, Jagannath V, Diaz AA, Velez JD, Letica A, Perez SN, Clark R, Caraco Y, Degen O, Park KH, Unal S, Wittke F, Hurtado K, Churchill C, Zhang Y, Fernsler D, Li J, Buchwald UK, Platt H. A Phase 3 Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Vaccine, Compared with PPSV23, in Adults >/=50 Years of Age (STRIDE-10). Vaccines (Basel). 2025 Mar 22;13(4):341. doi: 10.3390/vaccines13040341.

CH-PCN-00017, 11/2025