{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T09:24:01Z","timestamp":1764062641558,"version":"3.45.0"},"reference-count":29,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2025,11,24]],"date-time":"2025-11-24T00:00:00Z","timestamp":1763942400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Joint Construction Project of the Medical Technology Research and Development Plan of Henan Province","award":["LHGJ20240598"],"award-info":[{"award-number":["LHGJ20240598"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Objectives: This study systematically assessed the safety and immunogenicity of a new 13-valent pneumococcal conjugate vaccine (CRM197\/TT, PCV13i) against the licensed PCV13 vaccine in a cohort of Chinese children between 12 and 23 months of age. Methods: This is a phase III, randomized, double-blind trial (NCT04841369). A total of 528 participants were randomized 1:1 to receive two doses of either PCV13i experimental or the PCV13 control vaccine at a 2-month interval, with 517 participants completing the vaccinations. Results: The overall incidence of adverse events (37.12% vs. 32.70%, p = 0.134) and adverse reactions (24.81% vs. 21.61%, p = 0.221) was comparable between the experimental and control groups. Local adverse reactions were more frequent in the experimental group (10.00% vs. 6.12%, p = 0.021), such as erythema (7.88% vs. 4.02%, p = 0.008). Systemic adverse reactions, including fever (10.77% vs. 13.77%), showed no significant differences. No vaccine-related serious adverse events occurred. Immunogenicity assessments showed that seropositivity rates for most serotypes reached \u226596% in both groups, with eight serotypes achieving 100% seropositivity in the experimental group. PCV13i induced higher IgG geometric mean concentrations (GMCs) for serotypes 3, 7F, and 19F (p &lt; 0.05), whereas the control group showed higher GMCs for serotypes 1, 5, 6A, and 14 (p &lt; 0.05). Opsonophagocytic activity (OPA)-related geometric mean titers (GMTs) were superior for PCV13i against serotypes 7F (39,583 vs. 17,249, p &lt; 0.001) and 19F (1517 vs. 983, p = 0.028), but lower for serotype 5 (13 vs. 93, p &lt; 0.001). Conclusions: PCV13i demonstrated non-inferior immunogenicity and an acceptable safety profile in 12\u201323-month-old children.<\/jats:p>","DOI":"10.3390\/vaccines13121190","type":"journal-article","created":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T08:50:20Z","timestamp":1764060620000},"page":"1190","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The Safety and Immunogenicity of a 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197\/TT) in 12\u201323-Month Children: A Double-Blind, Randomized, Phase III Trial in China"],"prefix":"10.3390","volume":"13","author":[{"given":"Zhiqiang","family":"Xie","sequence":"first","affiliation":[{"name":"Henan Province Center for Disease Control and Prevention, Zhengzhou 450003, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-9516-7227","authenticated-orcid":false,"given":"Feiyu","family":"Wang","sequence":"additional","affiliation":[{"name":"CanSino Biologics Inc., Tianjin 300457, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lili","family":"Huang","sequence":"additional","affiliation":[{"name":"Henan Province Center for Disease Control and Prevention, Zhengzhou 450003, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haitao","family":"Huang","sequence":"additional","affiliation":[{"name":"CanSino Biologics Inc., Tianjin 300457, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guangwei","family":"Feng","sequence":"additional","affiliation":[{"name":"Henan Province Center for Disease Control and Prevention, Zhengzhou 450003, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xue","family":"Wang","sequence":"additional","affiliation":[{"name":"CanSino Biologics Inc., Tianjin 300457, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiebing","family":"Tan","sequence":"additional","affiliation":[{"name":"Henan Province Center for Disease Control and Prevention, Zhengzhou 450003, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaomin","family":"Ma","sequence":"additional","affiliation":[{"name":"CanSino Biologics Inc., Tianjin 300457, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wangyang","family":"You","sequence":"additional","affiliation":[{"name":"Henan Province Center for Disease Control and Prevention, Zhengzhou 450003, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaolong","family":"Li","sequence":"additional","affiliation":[{"name":"CanSino Biologics Inc., Tianjin 300457, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jinbo","family":"Gou","sequence":"additional","affiliation":[{"name":"CanSino Biologics Inc., Tianjin 300457, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yanxia","family":"Wang","sequence":"additional","affiliation":[{"name":"Henan Province Center for Disease Control and Prevention, Zhengzhou 450003, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,11,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"256","DOI":"10.1038\/s41579-024-01116-z","article-title":"Streptococcus pneumoniae epidemiology, pathogenesis and control","volume":"23","author":"Narciso","year":"2025","journal-title":"Nat. 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