{"id":8644,"date":"2025-11-05T09:41:48","date_gmt":"2025-11-05T07:41:48","guid":{"rendered":"https:\/\/www.msd.ch\/fr\/?page_id=8644"},"modified":"2025-11-05T09:41:49","modified_gmt":"2025-11-05T07:41:49","slug":"capvaxive-veroffentlichung-der-ergebnisse-klinischer-studien","status":"publish","type":"page","link":"https:\/\/www.msd.ch\/fr\/capvaxive-veroffentlichung-der-ergebnisse-klinischer-studien\/","title":{"rendered":"CAPVAXIVE &#8211; Publication des r\u00e9sultats d\u2019\u00e9tudes cliniques"},"content":{"rendered":"\n<h1 class=\"wp-block-heading\">Publication des r\u00e9sultats d\u2019\u00e9tudes cliniques<\/h1>\n\n\n\n<p>Les informations ci-dessous ainsi que les liens correspondant aux donn\u00e9es cliniques r\u00e9pondent aux exigences des articles 71 \u00e0 73 de l\u2019Ordonnance sur les m\u00e9dicaments (Ordonnance sur les m\u00e9dicaments, OM\u00e9d) et compl\u00e8tent les informations publi\u00e9es en lien avec l\u2019autorisation suisse des m\u00e9dicaments correspondants.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">CAPVAXIVE\u00ae<\/h2>\n\n\n\n<p>Vaccin pneumococcique polyosidique conjugu\u00e9 (21-valent). Solution injectable.<\/p>\n\n\n\n<p>1 dose (0,5 ml) contient:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 3<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype\u00a06A<sup>1\u00a0<\/sup>4\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 7F<sup>1\u00a0<\/sup>4\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 8<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 9N<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 10A<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 11A<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 12F<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 15A<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside pneumococcique provenant de deOAc15B (s\u00e9rotype\u00a015B d\u00e9-O-ac\u00e9tyl\u00e9)<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 16F<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 17F<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 19A<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 20A<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 22F<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 23A<sup>1<\/sup> 4\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 23B<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 24F<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype 31<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype\u00a033F<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n\n\n\n<li>Polyoside\u00a0pneumococcique de s\u00e9rotype\u00a035B<sup>1<\/sup>\u00a04\u00a0\u00b5g<\/li>\n<\/ul>\n\n\n\n<p class=\"has-small-font-size\"><sup>1\u00a0<\/sup>Conjugu\u00e9 \u00e0 la prot\u00e9ine vectrice CRM<sub>197<\/sub>. La prot\u00e9ine CRM<sub>197<\/sub>\u00a0est une toxine dipht\u00e9rique mutante non toxique (issue de\u00a0<em>Corynebacterium diphtheriae<\/em>\u00a0C7) exprim\u00e9e par recombinaison dans\u00a0<em>Pseudomonas fluorescens<\/em>.<br>1\u00a0dose (0,5\u00a0ml) contient environ 65\u00a0\u03bcg de prot\u00e9ine vectrice CRM<sub>197<\/sub>.<\/p>\n\n\n\n<p class=\"has-small-font-size\"><\/p>\n\n\n\n<p>Num\u00e9ro d\u2019autorisation: 69781<\/p>\n\n\n\n<p>Swissmedic Date d&#8217;autorisation: 23 septembre 2025<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>\u00c9tudes cliniques<\/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 des r\u00e9sultats d\u2019\u00e9tudes cliniques Les informations ci-dessous ainsi que les liens correspondant aux donn\u00e9es cliniques r\u00e9pondent aux exigences des articles 71 \u00e0 73 de l\u2019Ordonnance sur les m\u00e9dicaments (Ordonnance sur les m\u00e9dicaments, OM\u00e9d) et compl\u00e8tent les informations publi\u00e9es en lien avec l\u2019autorisation suisse des m\u00e9dicaments correspondants. CAPVAXIVE\u00ae Vaccin pneumococcique polyosidique conjugu\u00e9 (21-valent). Solution injectable. [&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-8644","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 - Publication des r\u00e9sultats d\u2019\u00e9tudes cliniques - msd.ch<\/title>\n<meta name=\"description\" content=\"Publication des r\u00e9sultats d\u2019\u00e9tudes cliniques CAPVAXIVE\u00aeVaccin pneumococcique polyosidique conjugu\u00e9 (21-valent). 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