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..

CAPVAXIVE®

CAPVAXIVE® (Pneumococcal 21-valent conjugate vaccine), solution for injection.

1 dose (0.5 ml) contains:

  • Pneumococcal polysaccharide serotype 31 4 µg
  • Pneumococcal polysaccharide serotype 6A1 4 µg
  • Pneumococcal polysaccharide serotype 7F1 4 µg
  • Pneumococcal polysaccharide serotype 81 4 µg
  • Pneumococcal polysaccharide serotype 9N1 4 µg
  • Pneumococcal polysaccharide serotype 10A1 4 µg
  • Pneumococcal polysaccharide serotype 11A1 4 µg
  • Pneumococcal polysaccharide serotype 12F1 4 µg
  • Pneumococcal polysaccharide serotype 15A1 4 µg
  • Pneumococcal polysaccharide from deOAc15B (de-O-acetylated serotype 15B)1 4 µg
  • Pneumococcal polysaccharide serotype 16F1 4 µg
  • Pneumococcal polysaccharide serotype 17F1 4 µg
  • Pneumococcal polysaccharide serotype 19A1 4 µg
  • Pneumococcal polysaccharide serotype 20A1 4 µg
  • Pneumococcal polysaccharide serotype 22F1 4 µg
  • Pneumococcal polysaccharide serotype 23A1 4 µg
  • Pneumococcal polysaccharide serotype 23B1 4 µg
  • Pneumococcal polysaccharide serotype 24F1 4 µg
  • Pneumococcal polysaccharide serotype 311 4 µg
  • Pneumococcal polysaccharide serotype 33F1 4 µg
  • Pneumococcal polysaccharide serotype 35B1 4 µg

1 Conjugated to CRM197 carrier protein.
CRM197 is a non-toxic mutant of diphtheria toxin (from Corynebacterium diphtheriae C7) and is expressed recombinantly in Pseudomonas fluorescens.
1 dose (0.5 ml) contains approximately 65 µg of CRM197 carrier protein.

Authorisation number: 69781

Date of Marketing Authorisation: 23-Sep-2025


Clinical Trials

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