{"id":9967,"date":"2025-11-05T08:35:15","date_gmt":"2025-11-05T07:35:15","guid":{"rendered":"https:\/\/www.msd.ch\/en\/?page_id=9967"},"modified":"2025-11-05T08:35:16","modified_gmt":"2025-11-05T07:35:16","slug":"capvaxive-veroffentlichung-der-ergebnisse-klinischer-studien","status":"publish","type":"page","link":"https:\/\/www.msd.ch\/en\/capvaxive-veroffentlichung-der-ergebnisse-klinischer-studien\/","title":{"rendered":"CAPVAXIVE &#8211; Publication of clinical trial results"},"content":{"rendered":"\n<h1 class=\"wp-block-heading\">Publication of clinical trial results<\/h1>\n\n\n\n<p>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..<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">CAPVAXIVE\u00ae<\/h2>\n\n\n\n<p>CAPVAXIVE\u00ae (Pneumococcal 21-valent conjugate vaccine), solution for injection.<\/p>\n\n\n\n<p>1 dose (0.5 ml) contains:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pneumococcal polysaccharide serotype 3<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 6A<sup>1\u00a0<\/sup>4\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 7F<sup>1\u00a0<\/sup>4\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 8<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 9N<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 10A<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 11A<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 12F<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 15A<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide from deOAc15B (de-O-acetylated serotype 15B)<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 16F<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 17F<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 19A<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 20A<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 22F<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 23A<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 23B<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 24F<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 31<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 33F<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Pneumococcal polysaccharide serotype 35B<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n<\/ul>\n\n\n\n<p class=\"has-small-font-size\"><sup>1\u00a0<\/sup>Conjugated to CRM197 carrier protein.<br>CRM<sub>197<\/sub> is a non-toxic mutant of diphtheria toxin (from <em>Corynebacterium diphtheriae<\/em> C7) and is expressed recombinantly in <em>Pseudomonas fluorescens.<\/em><br>1 <em>dose (0.5 ml) contains approximately 65 \u00b5g of CRM<sub>197<\/sub> carrier protein.<\/em><\/p>\n\n\n\n<p class=\"has-small-font-size\"><\/p>\n\n\n\n<p>Authorisation number: 69781<\/p>\n\n\n\n<p>Date of Marketing Authorisation: 23-Sep-2025<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><br><strong><strong>Clinical Trials<\/strong><\/strong><\/h4>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05425732\"><strong>Safety and Immunogenicity of V116 in Pneumococcal Vaccine-na\u00efve Adults (V116-003, STRIDE-3) &#8211; ClinicalTrials.gov<\/strong><\/a><\/p>\n\n\n\n<p>NCT05425732<\/p>\n\n\n\n<p>Publication:<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05464420\"><strong>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)&nbsp;&#8211; ClinicalTrials.gov<\/strong><\/a><\/p>\n\n\n\n<p>NCT05464420<\/p>\n\n\n\n<p>Publication:<\/p>\n\n\n\n<p>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:&nbsp;40543503<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05526716\"><strong>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<\/strong><\/a><\/p>\n\n\n\n<p>NCT05526716<\/p>\n\n\n\n<p>Publication:<\/p>\n\n\n\n<p>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<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05420961\"><strong>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) \u2013 ClinicalTrials.gov<\/strong><\/a><\/p>\n\n\n\n<p>NCT05420961<\/p>\n\n\n\n<p>Publication:<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05393037\"><strong>Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7) &#8211; ClinicalTrials.gov<\/strong><\/a><\/p>\n\n\n\n<p>NCT05393037<\/p>\n\n\n\n<p>Publication:<\/p>\n\n\n\n<p>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.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05696080\"><strong>Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008) (STRIDE-8) &#8211; ClinicalTrials.gov<\/strong><\/a><\/p>\n\n\n\n<p>NCT05696080<\/p>\n\n\n\n<p>Publication: not published<\/p>\n\n\n\n<p><strong>Poster: <a href=\"https:\/\/academic.oup.com\/ofid\/article\/12\/Supplement_1\/ofae631.252\/7988115?login=true\">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-Na\u00efve Adults 18\u201364 Years of Age with Increased Risk for Pneumococcal Disease | Open Forum Infectious Diseases | Oxford Academic<\/a><\/strong><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p>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<\/p>\n\n\n\n<p>Author Notes<\/p>\n\n\n\n<p>Open Forum Infectious Diseases, Volume 12, Issue Supplement_1, February 2025, ofae631.252, https:\/\/doi.org\/10.1093\/ofid\/ofae631.252<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05569954\"><strong>A Phase 3 Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Vaccine, Compared with PPSV23, in Adults \u226550 Years of Age (STRIDE-10)<\/strong><\/a><\/p>\n\n\n\n<p>NCT05569954<\/p>\n\n\n\n<p>Publication:<\/p>\n\n\n\n<p>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 &gt;\/=50 Years of Age (STRIDE-10). Vaccines (Basel). 2025 Mar 22;13(4):341. doi: 10.3390\/vaccines13040341.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><sup>CH-PCN-00017, 11\/2025<\/sup><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>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.. 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