{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T08:37:46Z","timestamp":1767861466910,"version":"3.49.0"},"reference-count":36,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2025,8,15]],"date-time":"2025-08-15T00:00:00Z","timestamp":1755216000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Sinovac Biotech Co., Ltd.","award":["2025JC-GXPT-011"],"award-info":[{"award-number":["2025JC-GXPT-011"]}]},{"name":"Construction of the Clinical Evaluation Technology Platform for Vaccines inShaanxi Province","award":["2025JC-GXPT-011"],"award-info":[{"award-number":["2025JC-GXPT-011"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Objectives: This randomized, double-blind, active-controlled non-inferiority phase 4 clinical trial was conducted to evaluate the immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine (PPSV23) compared to an active comparator vaccine. Methods: Pneumococcal vaccine-na\u00efve participants aged \u22652 years were randomly assigned in a 2:1 ratio to receive a single dose of either the investigational vaccine (n = 1199) or the comparator vaccine (n = 600). Immunogenicity was evaluated at baseline and 30 days post-vaccination by measuring serotype-specific IgG antibodies against all 23 pneumococcal serotypes using enzyme-linked immunosorbent assay. The primary outcome was seroconversion, defined as a \u2265two-fold increase in serotype-specific IgG antibody titers at day 30 compared to baseline. Results: At one month post-vaccination, seroconversion rates for each of the 23 serotypes ranged from 59.22% to 95.67% in the treatment group, compared to 59.66% to 94.07% in the control group. Non-inferiority was demonstrated for all serotypes, with the lower bounds of the 95% confidence intervals (95%CI) for rate differences exceeding the predefined \u221210% margin. Moreover, superiority was observed for 12 serotypes (6B, 23F, 1, 2, 4, 8, 9N, 9V, 11A, 15B, 17F and 18C), as the lower bounds of their 95%CI for rate differences were above 0. Adverse reactions were reported in 236 (19.68%) participants of the investigational group and 118 (19.67%) of the control group within 30 days post-vaccination, with no significant differences between groups. Conclusions: The PPSV23 vaccine administered among individual aged \u22652 years was safe, well tolerated and immunogenic, eliciting an immune response either comparable to or higher than control vaccine. These findings support its use as a safe and effective option for pneumococcal immunization.<\/jats:p>","DOI":"10.3390\/vaccines13080866","type":"journal-article","created":{"date-parts":[[2025,8,15]],"date-time":"2025-08-15T10:33:42Z","timestamp":1755254022000},"page":"866","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Safety and Immunogenicity of a 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23) in Chinese Children, Adults and the Elderly: A Phase 4, Randomized, Double-Blind, Active-Controlled Clinical Trial"],"prefix":"10.3390","volume":"13","author":[{"given":"Xiaoyu","family":"Liu","sequence":"first","affiliation":[{"name":"Shaanxi Provincial Center for Disease Control and Prevention, Xi\u2019an 710054, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gang","family":"Shi","sequence":"additional","affiliation":[{"name":"National Institute for Food and Drug Control, Beijing 102629, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuanyuan","family":"Dong","sequence":"additional","affiliation":[{"name":"Shaanxi Provincial Center for Disease Control and Prevention, Xi\u2019an 710054, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-6511-3723","authenticated-orcid":false,"given":"Wanqi","family":"Yang","sequence":"additional","affiliation":[{"name":"Clinical Research Department, Sinovac Biotech Co., Ltd., Beijing 100085, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yinan","family":"Wang","sequence":"additional","affiliation":[{"name":"Shaanxi Provincial Center for Disease Control and Prevention, Xi\u2019an 710054, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xianying","family":"Ye","sequence":"additional","affiliation":[{"name":"Clinical Research Department, Sinovac Biotech Co., Ltd., Beijing 100085, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juxiang","family":"Zhang","sequence":"additional","affiliation":[{"name":"Linwei Center for Disease Control and Prevention, Weinan 714009, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xinyi","family":"Yang","sequence":"additional","affiliation":[{"name":"Clinical Research Department, Sinovac Life Sciences Co., Ltd., Beijing 102601, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dan","family":"Yu","sequence":"additional","affiliation":[{"name":"Clinical Research Department, Sinovac Biotech Co., Ltd., Beijing 100085, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dan","family":"Song","sequence":"additional","affiliation":[{"name":"Linwei Center for Disease Control and Prevention, Weinan 714009, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuehong","family":"Ma","sequence":"additional","affiliation":[{"name":"Clinical Research Department, Sinovac Life Sciences Co., Ltd., Beijing 102601, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zeng","family":"Wang","sequence":"additional","affiliation":[{"name":"Clinical Research Department, Sinovac Biotech Co., Ltd., Beijing 100085, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hong","family":"Li","sequence":"additional","affiliation":[{"name":"National Institute for Food and Drug Control, Beijing 102629, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Weijun","family":"Hu","sequence":"additional","affiliation":[{"name":"Shaanxi Provincial Center for Disease Control and Prevention, Xi\u2019an 710054, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,8,15]]},"reference":[{"key":"ref_1","unstructured":"GBD 2016 Lower Respiratory Infections Collaborators (2018). Estimates of the global, regional, and national morbidity, mortality, and aetiologies of lower respiratory infections in 195 countries, 1990\u20132016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet Infect. Dis., 18, 1191\u20131210."},{"key":"ref_2","unstructured":"Hall, E., Wodi, A.P., Hamborsky, J., Morelli, V., and Schillie, S. (2021). Pneumococcal Disease. Epidemiology and Prevention of Vaccine Preventable Diseases, Center for Disease Control and Prevention. [14th ed.]."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"984","DOI":"10.1136\/thoraxjnl-2015-206780","article-title":"Which individuals are at increased risk of pneumococcal disease and why? Impact of COPD, asthma, smoking, diabetes, and\/or chronic heart disease on community-acquired pneumonia and invasive pneumococcal disease","volume":"70","author":"Torres","year":"2015","journal-title":"Thorax"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"355","DOI":"10.1038\/s41579-018-0001-8","article-title":"Streptococcus pneumoniae: Transmission, colonization and invasion","volume":"16","author":"Weiser","year":"2018","journal-title":"Nat. Rev. Microbiol."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"144","DOI":"10.1016\/S1473-3099(04)00938-7","article-title":"Streptococcus pneumoniae colonisation: The key to pneumococcal disease","volume":"4","author":"Bogaert","year":"2004","journal-title":"Lancet Infect. Dis."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"e00937-20","DOI":"10.1128\/mBio.00937-20","article-title":"A New Pneumococcal Capsule Type, 10D, is the 100th Serotype and Has a Large cps Fragment from an Oral Streptococcus","volume":"11","author":"Ganaie","year":"2020","journal-title":"mBio"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1","DOI":"10.15585\/mmwr.rr7203a1","article-title":"Pneumococcal Vaccine for Adults Aged \u226519 Years: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023","volume":"72","author":"Kobayashi","year":"2023","journal-title":"MMWR. Recomm. Rep."},{"key":"ref_8","doi-asserted-by":"crossref","unstructured":"Johnson, H.L., Deloria-Knoll, M., Levine, O.S., Stoszek, S.K., Freimanis Hance, L., Reithinger, R., Muenz, L.R., and O\u2019Brien, K.L. (2010). Systematic Evaluation of Serotypes Causing Invasive Pneumococcal Disease among Children Under Five: The Pneumococcal Global Serotype Project. PLoS Med., 7.","DOI":"10.1371\/journal.pmed.1000348"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"997","DOI":"10.1080\/14760584.2017.1360771","article-title":"A systematic review about Streptococcus pneumoniae serotype distribution in children in mainland of China before the PCV13 was licensed","volume":"16","author":"Lyu","year":"2017","journal-title":"Expert Rev. Vaccines"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"6065","DOI":"10.1016\/j.vaccine.2019.09.065","article-title":"Changes in serotype distribution and antimicrobial resistance of Streptococcus pneumoniae isolates from adult patients in Asia: Emergence of drug-resistant non-vaccine serotypes","volume":"38","author":"Kim","year":"2020","journal-title":"Vaccine"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"146","DOI":"10.1080\/21645515.2020.1757996","article-title":"Serotype distribution and clinical characteristics associated with Streptococcus pneumoniae among Chinese children and adults with invasive pneumococcal disease: A multicenter observational study","volume":"17","author":"Li","year":"2020","journal-title":"Hum. Vaccines Immunother."},{"key":"ref_12","unstructured":"World Health Organization (2021). Considerations for pneumococcal vaccination in older adults. Wkly. Epidemiol. Rec., 96, 217\u2013228."},{"key":"ref_13","unstructured":"World Health Organization (2019). Pneumococcal conjugate vaccines in infants and children under 5 years of age: WHO position paper\u2013February 2019. Wkly. Epidemiol. Rec., 94, 85\u2013104."},{"key":"ref_14","first-page":"1101","article-title":"Technical guideline on application of pneumococcal vaccine in China (2012)","volume":"33","author":"Qin","year":"2012","journal-title":"Zhonghua Liu Xing Bing Xue Za Zhi"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1343","DOI":"10.1080\/14760584.2022.2110074","article-title":"PPSV-23 recommendation and vaccination coverage in China: A cross-sectional survey among healthcare workers, older adults and chronic disease patients","volume":"21","author":"Lai","year":"2022","journal-title":"Expert Rev. Vaccines"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1179","DOI":"10.1097\/CM9.0000000000002790","article-title":"Influenza and pneumococcal vaccination coverage and associated factors in patients hospitalized with acute exacerbations of COPD in China: Findings from real-world data","volume":"137","author":"He","year":"2023","journal-title":"Chin. Med. J."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"249","DOI":"10.1080\/21645515.2018.1509648","article-title":"A phase III clinical trial to evaluate the safety and immunogenicity of 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy children, adults, and elderly","volume":"15","author":"Huang","year":"2018","journal-title":"Hum. Vaccines Immunother."},{"key":"ref_18","unstructured":"National Medical Products Administration (2025, August 01). Overseas Manufactured Drug: Pneumovax\u00ae, Basic Information for Approval Number SJ20140114, Available online: https:\/\/www.nmpa.gov.cn\/datasearch\/search-info.html?nmpa=aWQ9NDYyZjVlNjdhODcwMDRlYTVjMmIyMjJiMWM2MGE2ZDImaXRlbUlkPWZmODA4MDgxODNjYWQ3NTAwMTg0MDg4NjY1NzExODAw."},{"key":"ref_19","unstructured":"National Medical Products Administration (2025, August 11). Guidelines for Adverse Event Classification Standards for Clinical Trials of Pre-ventive Vaccines. (In Chinese)."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1016\/0022-1759(93)90270-H","article-title":"A modified enzyme-linked immunosorbent assay for measuring type-specific anti-pneumococcal capsular polysaccharide antibodies","volume":"164","author":"Konradsen","year":"1993","journal-title":"J. Immunol. Methods"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"2613","DOI":"10.1001\/jama.1977.03280250039019","article-title":"Protective efficacy of pneumococcal polysaccharide vaccines","volume":"238","author":"Smit","year":"1977","journal-title":"JAMA"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"1136","DOI":"10.1093\/infdis\/148.6.1136","article-title":"Considerations for Formulating the Second-Generation Pneumococcal Capsular Polysaccharide Vaccine with Emphasis on the Cross-Reactive Types Within Groups","volume":"148","author":"Robbins","year":"1983","journal-title":"J. Infect. Dis."},{"key":"ref_23","unstructured":"World Health Organization (2024, November 17). Immunization Agenda 2030: A Global Strategy to Leave No One Behind. Available online: https:\/\/www.who.int\/teams\/immunization-vaccines-and-biologicals\/strategies\/ia2030."},{"key":"ref_24","doi-asserted-by":"crossref","unstructured":"Chen, Y., Deng, W., Wang, S.-M., Mo, Q.-M., Jia, H., Wang, Q., Li, S.-G., Li, X., Yao, B.-D., and Liu, C.-J. (2011). Burden of Pneumonia and Meningitis Caused by Streptococcus pneumoniae in China among Children under 5 Years of Age: A Systematic Literature Review. PLoS ONE, 6.","DOI":"10.1371\/journal.pone.0027333"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"2567","DOI":"10.1007\/s40121-023-00878-y","article-title":"Disease Burden of Meningitis Caused by Streptococcus pneumoniae Among Under-Fives in China: A Systematic Review and Meta-analysis","volume":"12","author":"Wang","year":"2023","journal-title":"Infect. Dis. Ther."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"919","DOI":"10.4161\/hv.7.9.15996","article-title":"Antibody persistence ten years after first and second doses of 23-valent pneumococcal polysaccharide vaccine, and immunogenicity and safety of second and third doses in older adults","volume":"7","author":"Musher","year":"2011","journal-title":"Hum. Vaccines"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"839","DOI":"10.1016\/S1473-3099(14)70822-9","article-title":"Serotype-specific effectiveness and correlates of protection for the 13-valent pneumococcal conjugate vaccine: A postlicensure indirect cohort study","volume":"14","author":"Andrews","year":"2014","journal-title":"Lancet Infect. Dis."},{"key":"ref_28","doi-asserted-by":"crossref","unstructured":"Babb, R., Doyle, C.R., Pirofski, L.-A., and Goldberg, J.B. (2021). Isolation and Characterization of Human Monoclonal Antibodies to Pneumococcal Capsular Polysaccharide 3. Microbiol. Spectr., 9.","DOI":"10.1128\/Spectrum.01446-21"},{"key":"ref_29","doi-asserted-by":"crossref","unstructured":"Linley, E., Bell, A., Gritzfeld, J.F., and Borrow, R. (2019). Should Pneumococcal Serotype 3 Be Included in Serotype-Specific Immunoassays?. Vaccines, 7.","DOI":"10.3390\/vaccines7010004"},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1016\/j.jinf.2015.03.001","article-title":"Etiology of diarrhea among children under the age five in China: Results from a five-year surveillance","volume":"71","author":"Yu","year":"2015","journal-title":"J. Infect."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"2425","DOI":"10.1080\/21645515.2015.1055429","article-title":"Immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine in Chinese healthy population aged >2 years: A randomized, double-blinded, active control, phase III trial","volume":"11","author":"Kong","year":"2015","journal-title":"Hum. Vaccines Immunother."},{"key":"ref_32","unstructured":"World Health Organization (2024, November 17). Global Manual on Surveillance of Adverse Events Following Immunization. Available online: https:\/\/www.who.int\/publications\/i\/item\/9789241507769."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"2325","DOI":"10.1097\/CM9.0000000000003270","article-title":"Burden of non-communicable diseases in China and its provinces, 1990\u20132021: Results from the Global Burden of Disease Study 2021","volume":"137","author":"Liu","year":"2024","journal-title":"Chin. Med. J."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1016\/j.eclinm.2018.12.007","article-title":"Effectiveness of 23-Valent Polysaccharide Pneumococcal Vaccine and Changes in Invasive Pneumococcal Disease Incidence from 2000 to 2017 in Those Aged 65 and Over in England and Wales","volume":"6","author":"Djennad","year":"2018","journal-title":"eClinicalMedicine"},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"6802","DOI":"10.1016\/j.vaccine.2012.09.019","article-title":"Impact and effectiveness of 23-valent pneumococcal polysaccharide vaccine against invasive pneumococcal disease in the elderly in England and Wales","volume":"30","author":"Andrews","year":"2012","journal-title":"Vaccine"},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"2517489","DOI":"10.1080\/21645515.2025.2517489","article-title":"Immune persistence of a single dose of 23-valent pneumococcal polysaccharide vaccine: A 6-year follow-up","volume":"21","author":"Huang","year":"2025","journal-title":"Hum. Vaccines Immunother."}],"container-title":["Vaccines"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2076-393X\/13\/8\/866\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T18:28:12Z","timestamp":1760034492000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2076-393X\/13\/8\/866"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,15]]},"references-count":36,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2025,8]]}},"alternative-id":["vaccines13080866"],"URL":"https:\/\/doi.org\/10.3390\/vaccines13080866","relation":{},"ISSN":["2076-393X"],"issn-type":[{"value":"2076-393X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,15]]}}}