{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,2]],"date-time":"2026-11-02T21:57:02Z","timestamp":1793656622794,"version":"4.5.1"},"reference-count":40,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2021,12,23]],"date-time":"2021-12-23T00:00:00Z","timestamp":1640217600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,8,31]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Pneumococcal conjugate vaccines (PCVs) have significantly reduced pneumococcal disease, but disease from non-PCV serotypes remains. The safety, tolerability, and immunogenicity of a 20-valent PCV (PCV20) were evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This pivotal phase 3, randomized, double-blind study enrolled adults into 3 age groups (\u226560, 50\u201359, and 18\u201349 years) at US and Swedish sites. Participants were randomized to receive 1 PCV20 or 13-valent PCV (PCV13) dose. After 1 month, participants aged \u226560 years also received 1 dose of saline or 23-valent polysaccharide vaccine (PPSV23). Safety assessments included local reactions, systemic events, adverse events, serious adverse events, and newly diagnosed chronic medical conditions. Opsonophagocytic activity geometric mean titers 1 month after PCV20 were compared with 13 matched serotypes after PCV13 and 7 additional serotypes after PPSV23 in participants aged \u226560 years; noninferiority was declared if the lower bound of the 2-sided 95% confidence interval for the opsonophagocytic activity geometric mean titer ratio (ratio of PCV20\/saline to PCV13\/PPSV23 group) was &amp;gt;0.5. PCV20-elicited immune responses in younger participants were also bridged to those in 60\u201364-year-olds.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The severity and frequency of prompted local reactions and systemic events were similar after PCV20 or PCV13; no safety concerns were identified. Primary immunogenicity objectives were met, with immune responses after PCV20 noninferior to 13 matched serotypes after PCV13 and to 6 additional PPSV23 serotypes in participants aged \u226560 years; serotype 8 missed the statistical noninferiority criterion. PCV20 induced robust responses to all 20 vaccine serotypes across age groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>PCV20 was safe and well tolerated, with immunogenicity comparable to that of PCV13 or PPSV23. PCV20 is anticipated to expand protection against pneumococcal disease in adults.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registration<\/jats:title>\n                    <jats:p>NCT03760146.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciab990","type":"journal-article","created":{"date-parts":[[2021,12,22]],"date-time":"2021-12-22T15:13:02Z","timestamp":1640185982000},"page":"390-398","source":"Crossref","is-referenced-by-count":173,"title":["Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged \u226518 Years"],"prefix":"10.1093","volume":"75","author":[{"given":"Brandon","family":"Essink","sequence":"first","affiliation":[{"name":"Meridian Clinical Research , Omaha, Nebraska ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charu","family":"Sabharwal","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Pearl River, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Cannon","sequence":"additional","affiliation":[{"name":"PMG Research of Wilmington , Wilmington, North Carolina ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Frenck","sequence":"additional","affiliation":[{"name":"Cincinnati Children\u2019s Hospital , Cincinnati, Ohio ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Himal","family":"Lal","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Collegeville, Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xia","family":"Xu","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Collegeville, Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vani","family":"Sundaraiyer","sequence":"additional","affiliation":[{"name":"Syneos Health , Somerset, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yahong","family":"Peng","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Collegeville, Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Moyer","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Collegeville, Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael W","family":"Pride","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Pearl River, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ingrid L","family":"Scully","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Pearl River, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathrin U","family":"Jansen","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Pearl River, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William C","family":"Gruber","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Pearl River, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel A","family":"Scott","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Collegeville, Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendy","family":"Watson","sequence":"additional","affiliation":[{"name":"Vaccine Research and Development, Pfizer Inc , Collegeville, Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,12,23]]},"reference":[{"key":"2024111211015048900_CIT0001","first-page":"129","article-title":"Pneumococcal vaccines WHO position paper\u20132012.","volume":"87","author":"World Health Organization.","year":"2012","journal-title":"Wkly Epidemiol Rec"},{"key":"2024111211015048900_CIT0002","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1111\/j.1469-0691.2012.03937.x","article-title":"Understanding the burden of pneumococcal disease in adults.","volume":"18","author":"Blasi","year":"2012","journal-title":"Clin Microbiol 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