Publication des résultats d’études cliniques

Les informations ci-dessous ainsi que les liens correspondant aux données cliniques répondent aux exigences des articles 71 à 73 de l’Ordonnance sur les médicaments (Ordonnance sur les médicaments, OMéd) et complètent les informations publiées en lien avec l’autorisation suisse des médicaments correspondants.

CAPVAXIVE®

Vaccin pneumococcique polyosidique conjugué (21-valent). Solution injectable.

1 dose (0,5 ml) contient:

  • Polyoside pneumococcique de sérotype 31 4 µg
  • Polyoside pneumococcique de sérotype 6A1 4 µg
  • Polyoside pneumococcique de sérotype 7F1 4 µg
  • Polyoside pneumococcique de sérotype 81 4 µg
  • Polyoside pneumococcique de sérotype 9N1 4 µg
  • Polyoside pneumococcique de sérotype 10A1 4 µg
  • Polyoside pneumococcique de sérotype 11A1 4 µg
  • Polyoside pneumococcique de sérotype 12F1 4 µg
  • Polyoside pneumococcique de sérotype 15A1 4 µg
  • Polyoside pneumococcique provenant de deOAc15B (sérotype 15B dé-O-acétylé)1 4 µg
  • Polyoside pneumococcique de sérotype 16F1 4 µg
  • Polyoside pneumococcique de sérotype 17F1 4 µg
  • Polyoside pneumococcique de sérotype 19A1 4 µg
  • Polyoside pneumococcique de sérotype 20A1 4 µg
  • Polyoside pneumococcique de sérotype 22F1 4 µg
  • Polyoside pneumococcique de sérotype 23A1 4 µg
  • Polyoside pneumococcique de sérotype 23B1 4 µg
  • Polyoside pneumococcique de sérotype 24F1 4 µg
  • Polyoside pneumococcique de sérotype 311 4 µg
  • Polyoside pneumococcique de sérotype 33F1 4 µg
  • Polyoside pneumococcique de sérotype 35B1 4 µg

1 Conjugué à la protéine vectrice CRM197. La protéine CRM197 est une toxine diphtérique mutante non toxique (issue de Corynebacterium diphtheriae C7) exprimée par recombinaison dans Pseudomonas fluorescens.
1 dose (0,5 ml) contient environ 65 μg de protéine vectrice CRM197.

Numéro d’autorisation: 69781

Swissmedic Date d’autorisation: 23 septembre 2025

Études cliniques

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