{"id":12823,"date":"2025-10-31T09:38:01","date_gmt":"2025-10-31T08:38:01","guid":{"rendered":"https:\/\/www.msd.ch\/de\/?page_id=12823"},"modified":"2025-11-05T08:36:29","modified_gmt":"2025-11-05T07:36:29","slug":"capvaxive-veroffentlichung-der-ergebnisse-klinischer-studien","status":"publish","type":"page","link":"https:\/\/www.msd.ch\/de\/capvaxive-veroffentlichung-der-ergebnisse-klinischer-studien\/","title":{"rendered":"CAPVAXIVE &#8211; Ver\u00f6ffentlichung der Ergebnisse klinischer Studien"},"content":{"rendered":"\n<h1 class=\"wp-block-heading\">Ver\u00f6ffentlichung von Ergebnissen klinischer Studien<\/h1>\n\n\n\n<p>Die nachfolgenden Informationen und die entsprechenden Links zu den klinischen Daten erf\u00fcllen die Anforderungen der Artikel 71-73 der Arzneimittelverordnung (VAM). Sie erg\u00e4nzen die Informationen, die im Zusammenhang mit der schweizerischen Zulassung des Arzneimittels ver\u00f6ffentlicht wurden.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">CAPVAXIVE\u00ae<\/h2>\n\n\n\n<p>Pneumokokken-Polysaccharid-Konjugatimpfstoff (21-valent) zur Injektion.<\/p>\n\n\n\n<p>1 Dosis (0,5 ml) enth\u00e4lt:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pneumokokken-Polysaccharid-Serotyp 3<sup>1<\/sup>&nbsp;4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 6A<sup>1&nbsp;<\/sup>4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 7F<sup>1&nbsp;<\/sup>4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 8<sup>1<\/sup>&nbsp;4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 9N<sup>1<\/sup>&nbsp;4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 10A<sup>1<\/sup>&nbsp;4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 11A<sup>1<\/sup> 4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 12F<sup>1<\/sup> 4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 15A<sup>1<\/sup> 4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid von deOAc15B (de-O-acetylierter Serotyp 15B)<sup>1<\/sup> 4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 16F<sup>1<\/sup> 4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 17F<sup>1<\/sup>&nbsp;4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 19A<sup>1<\/sup> 4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 20A<sup>1<\/sup> 4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 22F<sup>1<\/sup>&nbsp;4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 23A<sup>1<\/sup> 4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 23B<sup>1<\/sup>&nbsp;4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 24F<sup>1<\/sup>&nbsp;4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 31<sup>1<\/sup>&nbsp;4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 33F<sup>1<\/sup>&nbsp;4&nbsp;\u00b5g<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid-Serotyp 35B<sup>1<\/sup>&nbsp;4&nbsp;\u00b5g<\/li>\n<\/ul>\n\n\n\n<p class=\"has-small-font-size\"><sup>1&nbsp;<\/sup>Konjugiert an CRM<sub>197<\/sub>-Tr\u00e4gerprotein. CRM<sub>197<\/sub>&nbsp;ist eine nicht-toxische Mutante des Diphtherie-Toxins (aus&nbsp;<em>Corynebacterium diphtheriae<\/em>&nbsp;C7) und wurde rekombinant exprimiert in&nbsp;<em>Pseudomonas fluorescens<\/em>.<br>1 Dosis (0,5&nbsp;ml) enth\u00e4lt etwa 65&nbsp;\u03bcg CRM<sub>197<\/sub>&nbsp;Tr\u00e4gerprotein.<\/p>\n\n\n\n<p class=\"has-small-font-size\"><\/p>\n\n\n\n<p>Swissmedic Zulassungsnummer: 69781<\/p>\n\n\n\n<p>Swissmedic Zulassungsdatum: 23. September 2025<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><br><strong>Klinische Studien<\/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>Ver\u00f6ffentlichung von Ergebnissen klinischer Studien Die nachfolgenden Informationen und die entsprechenden Links zu den klinischen Daten erf\u00fcllen die Anforderungen der Artikel 71-73 der Arzneimittelverordnung (VAM). Sie erg\u00e4nzen die Informationen, die im Zusammenhang mit der schweizerischen Zulassung des Arzneimittels ver\u00f6ffentlicht wurden. CAPVAXIVE\u00ae Pneumokokken-Polysaccharid-Konjugatimpfstoff (21-valent) zur Injektion. 1 Dosis (0,5 ml) enth\u00e4lt: 1&nbsp;Konjugiert an CRM197-Tr\u00e4gerprotein. CRM197&nbsp;ist eine [&hellip;]<\/p>\n","protected":false},"author":282,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"bdl_company_name":[],"bdl_item_external_link":[],"editor_notices":[],"footnotes":""},"class_list":["post-12823","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.9.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CAPVAXIVE - Ver\u00f6ffentlichung der Ergebnisse klinischer Studien - msd.ch<\/title>\n<meta name=\"description\" content=\"Ver\u00f6ffentlichung von Ergebnissen klinischer Studien von CAPVAXIVE\u00aePneumokokken-Polysaccharid-Konjugatimpfstoff (21-valent) zur Injektion.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.msd.ch\/de\/capvaxive-veroffentlichung-der-ergebnisse-klinischer-studien\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CAPVAXIVE - Ver\u00f6ffentlichung der Ergebnisse klinischer Studien - msd.ch\" \/>\n<meta property=\"og:description\" content=\"Ver\u00f6ffentlichung von Ergebnissen klinischer Studien von CAPVAXIVE\u00aePneumokokken-Polysaccharid-Konjugatimpfstoff (21-valent) zur Injektion.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.msd.ch\/de\/capvaxive-veroffentlichung-der-ergebnisse-klinischer-studien\/\" \/>\n<meta property=\"og:site_name\" content=\"msd.ch\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-05T07:36:29+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.msd.ch\/de\/capvaxive-veroffentlichung-der-ergebnisse-klinischer-studien\/\",\"url\":\"https:\/\/www.msd.ch\/de\/capvaxive-veroffentlichung-der-ergebnisse-klinischer-studien\/\",\"name\":\"CAPVAXIVE - Ver\u00f6ffentlichung der Ergebnisse klinischer Studien - msd.ch\",\"isPartOf\":{\"@id\":\"https:\/\/www.msd.ch\/de\/#website\"},\"datePublished\":\"2025-10-31T08:38:01+00:00\",\"dateModified\":\"2025-11-05T07:36:29+00:00\",\"description\":\"Ver\u00f6ffentlichung von Ergebnissen klinischer Studien von CAPVAXIVE\u00aePneumokokken-Polysaccharid-Konjugatimpfstoff (21-valent) zur Injektion.\",\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.msd.ch\/de\/capvaxive-veroffentlichung-der-ergebnisse-klinischer-studien\/\"]}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.msd.ch\/de\/#website\",\"url\":\"https:\/\/www.msd.ch\/de\/\",\"name\":\"msd.ch\",\"description\":\"MSD erforscht und entwickelt Medikamente und Impfstoffe, die Leben retten und die Gesundheit von Patienten verbessern sollen. 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