{"id":8390,"date":"2024-03-11T09:43:40","date_gmt":"2024-03-11T08:43:40","guid":{"rendered":"https:\/\/www.msd.ch\/de\/?page_id=8390"},"modified":"2024-03-11T09:43:55","modified_gmt":"2024-03-11T08:43:55","slug":"vaxneuvance-publication-of-clinical-trial-results","status":"publish","type":"page","link":"https:\/\/www.msd.ch\/de\/vaxneuvance-publication-of-clinical-trial-results\/","title":{"rendered":"VAXNEUVANCE &#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 Heilmittelverordnung (HMV). 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\">VAXNEUVANCE\u00ae<\/h2>\n\n\n\n<p>Pneumokokken-Polysaccharid-Konjugatimpfstoff (15-valent, adsorbiert). Suspension 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 1<sup>1,2<\/sup>&nbsp;2,0&nbsp;Mikrogramm<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 3<sup>1,2<\/sup>&nbsp;2,0&nbsp;Mikrogramm<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 4<sup>1,2<\/sup>&nbsp;2,0&nbsp;Mikrogramm<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid &#8211; Serotyp 5<sup>1,2<\/sup>&nbsp;2,0&nbsp;Mikrogramm<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 6A<sup>1,2<\/sup>&nbsp;2,0&nbsp;Mikrogramm<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 6B<sup>1,2<\/sup>&nbsp;4,0&nbsp;Mikrogramm<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 7F<sup>1,2<\/sup>&nbsp;2,0&nbsp;Mikrogramm<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 9V<sup>1,2<\/sup>&nbsp;2,0&nbsp;Mikrogramm<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 14<sup>1,2<\/sup>&nbsp;2,0&nbsp;Mikrogramm<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 18C<sup>1,2<\/sup>&nbsp;2,0&nbsp;Mikrogramm<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 19A<sup>1,2<\/sup>&nbsp;2,0&nbsp;Mikrogramm<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 19F<sup>1,2<\/sup>&nbsp;2,0&nbsp;Mikrogramm<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 22F<sup>1,2<\/sup>&nbsp;2,0&nbsp;Mikrogramm<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 23F<sup>1,2<\/sup>&nbsp;2,0&nbsp;Mikrogramm<\/li>\n\n\n\n<li>Pneumokokken-Polysaccharid Serotyp 33F<sup>1,2<\/sup>&nbsp;2,0&nbsp;Mikrogramm<\/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><sup>2&nbsp;<\/sup>Adsorbiert an Aluminiumphosphat-Adjuvans.<\/p>\n\n\n\n<p class=\"has-small-font-size\">1 Dosis (0,5&nbsp;ml) enth\u00e4lt 125&nbsp;Mikrogramm Aluminium (Al<sup>3+<\/sup>) und etwa 30&nbsp;Mikrogramm CRM<sub>197<\/sub>-Tr\u00e4gerprotein.<\/p>\n\n\n\n<p>Swissmedic Zulassungsnummer: 68752<\/p>\n\n\n\n<p>Swissmedic Zulassungsdatum: 14. Februar 2023<\/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\/ct2\/show\/NCT03950622?term=v114&amp;draw=4&amp;rank=8\">Safety and Immunogenicity of V114 in Healthy Adults (V114-019\/PNEU-AGE) &#8211; ClinicalTrials.gov<\/a><br>NCT03950622<\/p>\n\n\n\n<p><strong>Publication:<\/strong><br>Platt HL, Cardona JF, Haranaka M, Schwartz HI, Narejos Perez S, Dowell A, Chang CJ, Dagan R, Tamms GM, Sterling T, Morgan L, Shi Y, Pedley A, Musey LK, Buchwald UK. A phase 3 trial of safety, tolerability, and immunogenicity of V114, 15-valent pneumococcal conjugate vaccine, compared with 13-valent pneumococcal conjugate vaccine in adults 50 years of age and older (PNEU-AGE). Vaccine. 2022 Jan 3;40(1):162-172. doi: 10.1016\/j.vaccine.2021.08.049. Epub 2021 Sep 8. PMID: 34507861.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03480763?term=v114&amp;draw=3&amp;rank=16\">A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX\u212223 in Healthy Adults 50 Years of Age or Older (V114-016\/PNEU-PATH) &#8211; ClinicalTrials.gov<\/a><br>NCT03480763<\/p>\n\n\n\n<p><strong>Publication:<\/strong><br>Song JY, Chang CJ, Andrews C, Diez-Domingo J, Oh MD, Dagan R, Hartzel J, Pedley A, Li J, Sterling T, Tamms G, Chiarappa JA, Lutkiewicz J, Musey L, Tu Y, Buchwald UK; V114-016 (PNEU-PATH) study group. Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged\u202f\u226550\u202fyears: A randomized phase III trial (PNEU-PATH). Vaccine. 2021 Oct 15;39(43):6422-6436. doi: 10.1016\/j.vaccine.2021.08.038. Epub 2021 Sep 4. PMID: 34489128.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02573181?term=v114&amp;draw=3&amp;rank=14\">Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13\u2122 in PPSV23-vaccinated Healthy Adults \u226565 Years of Age (V114-007) &#8211; ClinicalTrials.gov<\/a><br>NCT02573181<\/p>\n\n\n\n<p><strong>Publication:<\/strong><br>Peterson JT, Stacey HL, MacNair JE, Li J, Hartzel JS, Sterling TM, Benner P, Tamms GM, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults \u226565 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Hum Vaccin Immunother. 2019;15(3):540-548. doi: 10.1080\/21645515.2018.1532250. Epub 2018 Nov 14. PMID: 30427749; PMCID: PMC6605723.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03615482?term=v114&amp;draw=3&amp;rank=19\">A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021\/PNEU-FLU) &#8211; ClinicalTrials.gov<\/a><br>NCT03615482<\/p>\n\n\n\n<p><strong>Publication:<\/strong> <br>Severance R, Schwartz H, Dagan R, Connor L, Li J, Pedley A, Hartzel J, Sterling TM, Nolan KM, Tamms GM, Musey LK, Buchwald UK. Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, administered concomitantly with influenza vaccine in healthy adults aged \u226550 years: a randomized phase 3 trial (PNEU-FLU). Hum Vaccin Immunother. 2022 Dec 31;18(1):1-14. doi: 10.1080\/21645515.2021.1976581. Epub 2021 Nov 2. PMID: 34726574; PMCID: PMC8920144.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><br><strong>P\u00e4diatrische Erweiterung<\/strong><\/h4>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03885934?cond=Pneumococcal%20Infections&amp;intr=Vaccination&amp;titles=A%20Phase%203,%20Multicenter,%20Randomized,%20Double-blind,%20Active%20Comparator-controlled%20Study%20to%20Evaluate%20the%20Safety,%20Tolerability,%20and%20Immunogenicity%20of%20Catch-up%20Vaccination%20Regimens%20of%20V114%20in%20Healthy%20Infants,%20Children,%20and%20Adolescents%20(PNEU-%20PLAN)&amp;aggFilters=ages:child&amp;rank=1\">A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Catch up Vaccination Regimens of V114 in Healthy Infants, Children, and Adolescents (PNEU-PLAN)<\/a><br>NCT03885934<\/p>\n\n\n\n<p><strong>Publication:<\/strong><br>Banniettis N, Wysocki J, Szenborn L, Phongsamart W, Pitisuttithum P, Ramet M, Richmond P, Shi Y, Dagan R, Good L, Papa M, Lupinacci R, McFetridge R, Tamms G, Churchill C, Musey L, Bickham K; V114-024 PNEU-PLAN study group. A phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of catch-up vaccination regimens of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants, children, and adolescents (PNEU-PLAN). Vaccine. 2022 Oct 19;40(44):6315-6325. doi: 10.1016\/j.vaccine.2022.09.003. Epub 2022 Sep 21.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04031846?cond=Pneumococcal%20Infections&amp;intr=Vaccination&amp;titles=A%20phase%203,%20multicenter,%20randomized,%20double-blind,%20active-comparator-controlled%20study%20to%20evaluate%20the%20safety,%20tolerability,%20and%20immunogenicity%20of%20a%204-dose%20regimen%20of%20V114,%20a%2015-valent%20pneumococcal%20conjugate%20vaccine,%20in%20healthy%20infants%20(PNEU-PED)&amp;aggFilters=ages:child&amp;id=NCT04031846&amp;rank=1\">A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (PNEU-PED-EU-1)<\/a><br>NCT04031846<\/p>\n\n\n\n<p><strong>Publication:<\/strong><br>Martinon-Torres F, Wysocki J, Szenborn L, Carmona-Martinez A, Poder A, Dagan R, Richmond P, Gilbert C, Trudel MC, Flores S, Lupinacci R, McFetridge R, Wiedmann RT, Chen Q, Gerrits H, Banniettis N, Musey L, Bickham K, Kaminski J; V114-025 PNEU-PED-EU-1 study group. A Phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V114 compared with PCV13 in healthy infants (PNEU-PED-EU-1). Vaccine. 2023 May 16;41(21):3387-3398. doi: 10.1016\/j.vaccine.2023.04.036. Epub 2023 Apr 25. PMID: 37105892<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03620162?cond=Pneumococcal%20Infections&amp;intr=Vaccination&amp;titles=A%20Phase%203,%20Multicenter,%20Randomized,%20Double-blind%20Study%20to%20Evaluate%20the%20Interchangeability%20of%20V114%20and%20Prevnar%2013%E2%84%A2%20with%20Respect%20to%20Safety,%20Tolerability,%20and%20Immunogenicity%20in%20Healthy%20Infants%20(PNEU-DIRECTION)&amp;aggFilters=ages:child&amp;rank=1#study-overview\">A phase 3, multicenter, randomized, double-blind study to evaluate the interchangeability of V114, a 15-valent pneumococcal conjugate vaccine, and PCV13 with respect to safety, tolerability, and immunogenicity in healthy infants (PNEU-DIRECTION)<\/a><br>NCT03620162<\/p>\n\n\n\n<p><strong>Publication:<\/strong><br>Bili A, Dobson S, Quinones J, Phongsamart W, Oberdorfer P, Kosalaraksa P, Dagan R, Richmond P, Wilck M, Vallejos W, Nunn C, McFetridge R, Tamms G, Fu R, Lupinacci R, Musey L, Banniettis N, Bickham K; V114-027 PNEU-DIRECTION study group. A phase 3, multicenter, randomized, double-blind study to evaluate the interchangeability of V114, a 15-valent pneumococcal conjugate vaccine, and PCV13 with respect to safety, tolerability, and immunogenicity in healthy infants (PNEU-DIRECTION). Vaccine. 2023 Jan 16;41(3):657-665. doi: 10.1016\/j.vaccine.2022.10.072. Epub 2022 Dec 13. PMID: 36522265<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03893448?cond=Pneumococcal%20Infections&amp;intr=Vaccination&amp;titles=A%20Phase%203,%20Multicenter,%20Randomized,%20Double-blind,%20Active-Comparator-controlled%20Study%20to%20Evaluate%20the%20Safety,%20Tolerability,%20and%20Immunogenicity%20of%20a%204-dose%20Regimen%20of%20V114%20in%20Healthy%20Infants%20(PNEU-PED)&amp;aggFilters=ages:child&amp;rank=1\">A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4 dose Regimen of V114 in Healthy Infants (PNEU-PED)<\/a><br>NCT03893448<\/p>\n\n\n\n<p><strong>Publication:<\/strong><br>Lupinacci R, Rupp R, Wittawatmongkol O, Jones J, Quinones J, Ulukol B, Dagan R, Richmond P, Stek JE, Romero L, Koseoglu S, Tamms G, McFetridge R, Li J, Cheon K, Musey L, Banniettis N, Bickham K; V114-029 PNEU-PED study group. A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED). Vaccine. 2023 Jan 27;41(5):1142-1152. doi: 10.1016\/j.vaccine.2022.12.054. Epub 2023 Jan 6. PMID: 36621410<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03692871?cond=Pneumococcal%20Infections&amp;intr=Vaccination&amp;titles=A%20Phase%203,%20Multicenter,%20Randomized,%20Double-blind,%20Active%20Comparator-controlled%20Study%20to%20Evaluate%20the%20Safety%20and%20Tolerability%20of%20V114%20in%20Healthy%20Infants%20(PNEU-LINK)&amp;aggFilters=ages:child&amp;rank=1\">A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)<\/a><br>NCT03692871<\/p>\n\n\n\n<p><strong>Publication:<\/strong><br>Banniettis N, Horn M, Sadarangani M, Patel SM, Greenberg D, Oberdorfer P, Klein NP, Rupp R, Dagan R, Richmond P, Lumley J, Zhou W, Shi Y, Tamms G, Feemster K, Lupinacci R, Musey L, Bickham K; V114-031 (PNEU-LINK) study group. Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study. Pediatrics. 2023 Jul 1;152(1):e2022060428. doi: 10.1542\/peds.2022-060428. PMID: 37309607<\/p>\n\n\n\n<p><sup>CH-PVC-00033, 03\/2024<\/sup><\/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 Heilmittelverordnung (HMV). Sie erg\u00e4nzen die Informationen, die im Zusammenhang mit der schweizerischen Zulassung des Arzneimittels ver\u00f6ffentlicht wurden. VAXNEUVANCE\u00ae Pneumokokken-Polysaccharid-Konjugatimpfstoff (15-valent, adsorbiert). Suspension zur Injektion. 1 Dosis (0,5 ml) enth\u00e4lt: 1&nbsp;Konjugiert an CRM197-Tr\u00e4gerprotein. [&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-8390","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>VAXNEUVANCE - Ver\u00f6ffentlichung der Ergebnisse klinischer Studien - msd.ch<\/title>\n<meta name=\"description\" content=\"Ver\u00f6ffentlichung von Ergebnissen klinischer Studien zu VAXNEUVANCE Pneumokokken-Polysaccharid-Konjugatimpfstoff (15-valent, adsorbiert), Suspension zur Injektion, die am 14. 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