Evidence map›Paper›PMID 35926726›Full record

Trial reportVirologica Sinica2022

Efficacy, safety and immunogenicity of hexavalent rotavirus vaccine in Chinese infants.

Zhiwei Wu, Qingliang Li, Yan Liu, Huakun Lv, Zhaojun Mo, Fangjun Li, Qingchuan Yu, Fei Jin, Wei Chen, Yong Zhang and 42 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Virologica Sinica, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 17% of its field
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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
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  4. Article
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  7. Review
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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

52 authors at 11 institutions in 2 countries.

Zhiwei WuHebei Center for Disease Control and Prevention, Shijiazhuang, 050021, China.
Qingliang LiNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Yan LiuNational Institutes for Food and Drug Control, Beijing, 100050, China.
Huakun LvZhejiang Center for Disease Control and Prevention, Hangzhou, 310051, China.
Zhaojun MoGuangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning, 530028, China.
Fangjun LiHunan Center for Disease Control and Prevention, Changsha, 410005, China.
Qingchuan YuNational Institutes for Food and Drug Control, Beijing, 100050, China.
Fei JinHebei Center for Disease Control and Prevention, Shijiazhuang, 050021, China.
Wei ChenNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Yong ZhangNational Institutes for Food and Drug Control, Beijing, 100050, China.
Teng HuangGuangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning, 530028, China.
Xiaosong HuZhejiang Center for Disease Control and Prevention, Hangzhou, 310051, China.
Wei XiaHunan Center for Disease Control and Prevention, Changsha, 410005, China.
Jiamei GaoNational Institutes for Food and Drug Control, Beijing, 100050, China.
Haisong ZhouZhengding County Center for Disease Control and Prevention, Shijiazhuang, 050800, China.
Xuan BaiNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Yueyue LiuNational Institutes for Food and Drug Control, Beijing, 100050, China.
Zhenzhen LiangZhejiang Center for Disease Control and Prevention, Hangzhou, 310051, China.
Zhijun JiangNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Yingping ChenZhejiang Center for Disease Control and Prevention, Hangzhou, 310051, China.
Jiuwei ZhangNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Jialiang DuNational Institutes for Food and Drug Control, Beijing, 100050, China.
Biao YangNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Bo XingZhejiang Center for Disease Control and Prevention, Hangzhou, 310051, China.
Yantao XingDaming County Center for Disease Control and Prevention, Handan, 056900, China.
Ben DongNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Qinghai YangLiucheng County Center for Disease Control and Prevention, Liuzhou, 545200, China.
Chen ShiNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Tingdong YanXiangtan County Center for Disease Control and Prevention, Xiangtan, 411228, China.
Bo RuanNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Haiyun ShiYuhuan County Center for Disease Control and Prevention, Taizhou, 317600, China.
Xingliang FanNational Institutes for Food and Drug Control, Beijing, 100050, China.
Dongyang FengNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Weigang LvYongnian County Center for Disease Control and Prevention, Handan, 056000, China.
Dong ZhangNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Xiangchu KongRongshui Miao Autonomous County Center for Disease Control and Prevention, Liuzhou, 545300, China.
Liuyifan ZhouNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Dinghong QueYou County Center for Disease Control and Prevention, Zhuzhou, 412315, China.
Hong ChenNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Zhongbing ChenLongyou County Center for Disease Control and Prevention, Quzhou, 324400, China.
Xiang GuoNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Weiwei ZhouLaishui County Center for Disease Control and Prevention, Baoding 074100, China.
Cong WuNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Qingrong ZhouJiangshan County Center for Disease Control and Prevention, Quzhou, 324100, China.
Yuqing LiuNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Jian QiaoNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Ying WangNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Xinguo LiNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Kai DuanNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China.
Yuliang ZhaoHebei Center for Disease Control and Prevention, Shijiazhuang, 050021, China. Electronic address: yuliang_zh@163.com.
Gelin XuNational Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Product Co., Ltd., Wuhan, 430207, China. Electronic address: gelinxu@qq.com.
Xiaoming YangChina National Biotec Group Company Limited, National Engineering Technology Research Center for Combined Vaccines, Wuhan, 430207, China. Electronic address: yangxiaoming@sinopharm.com.
Zhejiang Center for Disease Control and Prevention · CNNational Institutes for Food and Drug Control · CNHebei Provincial Center for Disease Control and Prevention · CNGuangxi Center for Disease Prevention and Control · CNHunan Provincial Center for Disease Control and Prevention · CNLiu Zhou Center for Disease Prevention and Control · CNTaiwan Centers for Disease Control · TWChina National Pharmaceutical Group Corporation (China) · CNNingxia Center for Diseases Prevention and Control · CNWuhan Institute of Technology · CNXian Center for Disease Control and Prevention · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A randomized, double-blind, placebo-controlled multicenter trial was conducted in healthy Chinese infants to assess the efficacy and safety of a hexavalent live human-bovine reassortant rotavirus vaccine (HRV) against rotavirus gastroenteritis (RVGE). A total of 6400 participants aged 6-12 weeks were enrolled and randomly assigned to either HRV (n ​= ​3200) or placebo (n ​= ​3200) group. All the subjects received three oral doses of vaccine four weeks apart. The vaccine efficacy (VE) against RVGE caused by rotavirus serotypes contained in HRV was evaluated from 14 days after three doses of administration up until the end of the second rotavirus season. VE against severe RVGE, VE against RVGE hospitalization caused by serotypes contained in HRV, and VE against RVGE, severe RVGE, and RVGE hospitalization caused by natural infection of any serotype of rotavirus were also investigated. All adverse events (AEs) were collected for 30 days after each dose. Serious AEs (SAEs) and intussusception cases were collected during the entire study. Our data showed that VE against RVGE caused by serotypes contained in HRV was 69.21% (95%CI: 53.31-79.69). VE against severe RVGE and RVGE hospitalization caused by serotypes contained in HRV were 91.36% (95%CI: 78.45-96.53) and 89.21% (95%CI: 64.51-96.72) respectively. VE against RVGE, severe RVGE, and RVGE hospitalization caused by natural infection of any serotype of rotavirus were 62.88% (95%CI: 49.11-72.92), 85.51% (95%CI: 72.74-92.30) and 83.68% (95%CI: 61.34-93.11). Incidences of AEs from the first dose to one month post the third dose in HRV and placebo groups were comparable. There was no significant difference in incidences of SAEs in HRV and placebo groups. This study shows that this hexavalent reassortant rotavirus vaccine is an effective, well-tolerated, and safe vaccine for Chinese infants.

Indexed as

Enterovirus InfectionsGastroenteritisRotavirusRotavirus InfectionsRotavirus VaccinesAdministration, OralAnimalsCattleChinaHumansInfantVaccinationVaccines, AttenuatedVaccines, CombinedRotavirus VaccinesVaccines, AttenuatedVaccines, CombinedEfficacyInfantsRotavirus gastroenteritis (RVGE)SafetyVaccine

Identifiers

PMID35926726
PMCPMC9583109
OpenAlexW4289338343

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.