Evidence map›Paper›PMID 40872951›Full record

ArticleVaccines2025

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.

Xiaoyu Liu, Gang Shi, Yuanyuan Dong, Wanqi Yang, Yinan Wang, Xianying Ye, Juxiang Zhang, Xinyi Yang, Dan Yu, Dan Song and 4 more

Abstract read
In one paragraph

Article in Vaccines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Xiaoyu LiuShaanxi Provincial Center for Disease Control and Prevention, Xi'an 710054, China.
Gang ShiNational Institute for Food and Drug Control, Beijing 102629, China.
Yuanyuan DongShaanxi Provincial Center for Disease Control and Prevention, Xi'an 710054, China.
Wanqi YangClinical Research Department, Sinovac Biotech Co., Ltd., Beijing 100085, China.ORCID 0009-0008-6511-3723
Yinan WangShaanxi Provincial Center for Disease Control and Prevention, Xi'an 710054, China.
Xianying YeClinical Research Department, Sinovac Biotech Co., Ltd., Beijing 100085, China.
Juxiang ZhangLinwei Center for Disease Control and Prevention, Weinan 714009, China.
Xinyi YangClinical Research Department, Sinovac Life Sciences Co., Ltd., Beijing 102601, China.
Dan YuClinical Research Department, Sinovac Biotech Co., Ltd., Beijing 100085, China.
Dan SongLinwei Center for Disease Control and Prevention, Weinan 714009, China.
Yuehong MaClinical Research Department, Sinovac Life Sciences Co., Ltd., Beijing 102601, China.
Zeng WangClinical Research Department, Sinovac Biotech Co., Ltd., Beijing 100085, China.
Hong LiNational Institute for Food and Drug Control, Beijing 102629, China.
Weijun HuShaanxi Provincial Center for Disease Control and Prevention, Xi'an 710054, China.

Funding

Sinovac Biotech Co., Ltd. No.The Constructionof the ClinicalEvaluationTechnology Platform for Vaccines in Shaanxi Province 2025JC-GXPT-011
6 · The paper itself

Abstract

objectivesThis 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.

methodsPneumococcal vaccine-naïve participants aged ≥2 years were randomly assigned in a 2:1 ratio to receive a single dose of either the investigational vaccine (

resultsAt 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 -10% 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.

conclusionsThe PPSV23 vaccine administered among individual aged ≥2 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.

Indexed as

23-valent pneumococcal polysaccharide vaccineimmunogenicityrandomized clinical trialsafety

Identifiers

PMID40872951
PMCPMC12389771

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.