Evidence map›Paper›PMID 41680199›Full record

ArticleNPJ vaccines2026

A randomised trial of a bioreactor-produced EV-A71 vaccine for endemic control in children.

Kao-Pin Hwang, Quang Chan Luong, Yhu-Chering Huang, Chou-Cheng Lai, Phuc Hong Le, Mai Tuyet Thi Tran, Boon-Fatt Tan, Po-Yen Chen, Shun-Cheng Yang, Wei-Ting Liu and 7 more

Registry-linked trialAbstract read
In one paragraph

Article in NPJ vaccines, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05099029 (A Phase III, Multiple-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of an Adjuvanted, Inactivated Enterovirus 71), which is not on this 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.

NCT05099029 phase3active not recruitingnot on this map

A Phase III, Multiple-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of an Adjuvanted, Inactivated Enterovirus 71 (EV71) Vaccine in Healthy Infants and Children

TypeinterventionalSponsorEnimmune CorporationRan2018 to 2024Enrolled3,982ConditionsEnterovirus InfectionsArmsEV71 vaccine, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

17 authors.

Kao-Pin HwangDepartment of Paediatric Infectious Diseases, China Medical University Hospital and Children's Hospital, China Medical University, School of Medicine, Taichung City, Taiwan.
Quang Chan LuongDepartment of Disease Prevention and Control, Pasteur Institute, Ho Chi Minh City, Vietnam.
Yhu-Chering HuangDivision of Paediatric Infectious Diseases, Linkou Chang-Gung Memorial Hospital, Taoyuan City, Taiwan.
Chou-Cheng LaiDepartment of Paediatrics, Taipei Veterans General Hospital, Taipei City, Taiwan.
Phuc Hong LeNguyen Dinh Chieu Hospital, Ben Tre Province, Vietnam.
Mai Tuyet Thi TranVinh Long General Hospital, Vinh Long Province, Vietnam.
Boon-Fatt TanDepartment of Paediatrics, National Taiwan University Hospital, Hsinchu branch, Hsinchu City, Taiwan.
Po-Yen ChenSection of Infectious Disease, Taichung Veterans General Hospital, Taichung City, Taiwan.
Shun-Cheng YangDivision of Paediatric Infectious Diseases, Changhua Christian Children's Hospital, Changhua City, Taiwan.
Wei-Ting LiuEnimmune Corporation, Taichung City, Taiwan.
Nguyen Thi Thanh ThaoImmunology and Microbiology Department, Pasteur Institute, Ho Chi Minh City, Vietnam.
Pochun LeeAdimmune Corporation, Taichung City, Taiwan.
Shu-Ting LinEnimmune Corporation, Taichung City, Taiwan.
Chung-Cheng LiuEnimmune Corporation, Taichung City, Taiwan.
Chwen-Cheng ChenAdimmune Corporation, Taichung City, Taiwan.
Chin-Fen YangEnimmune Corporation, Taichung City, Taiwan. cyang01003@gmail.com.
Li-Min HuangDepartment of Paediatrics, National Taiwan University Children's Hospital, Taipei City, Taiwan. lmhuang@ntu.edu.tw.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Enterovirus (EV) A71 causes endemic outbreaks of hand-foot-mouth disease (HFMD) and herpangina in young children, occasionally leading to severe complications and fatal outcomes. We evaluated EnVAX-A71, a bioreactor-produced, aluminum-adjuvanted inactivated EV-A71 (B4/E59) vaccine, in a randomized, double-blind, placebo-controlled phase 3 trial in Taiwan and Vietnam. A total of 4011 children aged 2-71 months were randomized 3:2 to vaccine or placebo; the primary endpoint was laboratory-confirmed EV-A71-associated HFMD/herpangina, evaluated from 28 days after dose two over a follow-up of 1 to 2 years (median, 490 days). In the primary analysis (n = 3733), one case occurred in vaccine recipients versus 70 in placebo (0.3 vs 39.2 per 1000 person-years), yielding 99.2% vaccine efficacy (95% CI: 94.3-99.9, p < 0.001). Seroprotection (neutralizing antibody titer ≥1:32) reached 98.7% at day 56 and remained ≥98% through one year. No vaccine-group hospitalizations occurred versus 19 in placebo (100% efficacy, 95% CI: 90.6-100.0). Safety profiles were comparable between groups. These findings support EnVAX-A71 for endemic EV-A71 control (ClinicalTrials.gov NCT05099029).

Identifiers

PMID41680199
PMCPMC13009275

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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.