Evidence map›Paper›PMID 35746502›Full record

ArticleVaccines2022

Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously with Hepatitis B Virus Vaccine, Group A Meningococcal Polysaccharide Vaccine, Measles-Rubella Combined Vaccine and Japanese Encephalitis Vaccine: A Multi-Center, Randomized, Controlled Clinical Trial in China.

Xiaodong Liu, Shaoying Chang, Ruize Wang, Yanhui Xiao, Fangjun Li, Qing Xu, Shaobai Zhang, Xiao Chen, Shangxiao Zhang, Min Zhang and 14 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03519568 (Evaluating Immunogenicity and Safety Effect on Combined Immune Effect of EV71 Inactivated Vaccine and HepB、MPSV-A、MR、JE-L：A Multi-center Randomized Controlled Trial), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT03519568 phase4unknown statusnot on this map

Evaluating Immunogenicity and Safety Effect on Combined Immune Effect of EV71 Inactivated Vaccine and HepB、MPSV-A、MR、JE-L：A Multi-center Randomized Controlled Trial

TypeinterventionalSponsorShandong Province Centers for Disease Control and PreventionRan2018 to 2019Enrolled1,944ConditionsEnterovirus 71 Inactivated Vaccine, HFMDArmsEV71 (inoculation vaccine)
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Observational
  5. Review
  6. Review
  7. Review
  8. Article
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

24 authors.

Xiaodong LiuShandong Provincial Center for Disease Control and Prevention, Jinan 250014, China.ORCID 0000-0003-2117-765X
Shaoying ChangShanxi Provincial Center for Disease Control and Prevention, Taiyuan 030012, China.
Ruize WangShaanxi Provincial Center for Disease Control and Prevention, Xi'an 710054, China.
Yanhui XiaoChina National Biotec Group Company Limited, Beijing 100024, China.
Fangjun LiHunan Provincial Center for Disease Control and Prevention, Changsha 410005, China.
Qing XuShandong Provincial Center for Disease Control and Prevention, Jinan 250014, China.
Shaobai ZhangShaanxi Provincial Center for Disease Control and Prevention, Xi'an 710054, China.
Xiao ChenShanxi Provincial Center for Disease Control and Prevention, Taiyuan 030012, China.
Shangxiao ZhangHunan Provincial Center for Disease Control and Prevention, Changsha 410005, China.
Min ZhangChina National Biotec Group Company Limited, Beijing 100024, China.
Xiaoqi ChenWuhan Institute of Biological Products Company Limited, Wuhan 430200, China.
Qingfan CaoRushan City Center for Disease Control and Prevention, Rushan 264500, China.
Xiaoyu LiuShaanxi Provincial Center for Disease Control and Prevention, Xi'an 710054, China.
Hui WangShanxi Provincial Center for Disease Control and Prevention, Taiyuan 030012, China.
Daihong ZhanShimen County Center for Disease Control and Prevention, Changde 415300, China.
Haiping ChenChina National Biotec Group Company Limited, Beijing 100024, China.
Wei ChenWuhan Institute of Biological Products Company Limited, Wuhan 430200, China.
Jianyong JiangHaiyang City Center for Disease Control and Prevention, Haiyang 265199, China.
Chao ZhangShaanxi Provincial Center for Disease Control and Prevention, Xi'an 710054, China.ORCID 0000-0001-6384-4516
Haijiao WangShanxi Provincial Center for Disease Control and Prevention, Taiyuan 030012, China.
Lidong GaoHunan Provincial Center for Disease Control and Prevention, Changsha 410005, China.
Xuanwen ShiChina National Biotec Group Company Limited, Beijing 100024, China.
Xiaoming YangChina National Biotec Group Company Limited, Beijing 100024, China.
Aiqiang XuShandong Provincial Center for Disease Control and Prevention, Jinan 250014, China.

Funding

the Taishan Scholar Program of Shandong Province ts201511105
6 · The paper itself

Abstract

backgroundThe aim of this study was to investigate the immunogenicity and safety of the enterovirus 71 vaccine (EV71 vaccine) administered alone or simultaneously.

methodsA multi-center, open-label, randomized controlled trial was performed involving 1080 healthy infants aged 6 months or 8 months from Shandong, Shanxi, Shaanxi, and Hunan provinces. These infants were divided into four simultaneous administration groups and EV71 vaccine separate administration group. Blood samples were collected from the infants before the first vaccination and after the completion of the vaccination. This trial was registered in the Clinical Trials Registry (NCT03519568).

resultsA total of 895 were included in the per-protocol analysis. The seroconversion rates of antibodies against EV71 in four simultaneous administration groups (98.44% (189/192), 94.57% (122/129), 99.47% (187/188) and 98.45% (190/193)) were non-inferior to EV71 vaccine separate administration group (97.93% [189/193]) respectively. Fever was the most common adverse event, the pairwise comparison tests showed no difference in the incidence rate of solicited, systemic or local adverse events. Three serious adverse events related to the vaccination were reported.

conclusionsThe evidence of immunogenicity and safety supports that the EV71 vaccine administered simultaneously with vaccines need to be administered during the same period of time recommended in China.

Indexed as

foot and mouth diseasehandinactivated enterovirus 71 vaccineseparate administrationsimultaneous administration

Identifiers

PMID35746502
PMCPMC9230521

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Registered trials

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.