The DOI matches its Crossref record.
Efficacy, Safety, and Immunogenicity of an Enterovirus 71 Vaccine in China
Open accessAbstract
BACKGROUND: Enterovirus 71 (EV71) is one of the major causative agents of outbreaks of hand, foot, and mouth disease or herpangina worldwide. This phase 3 trial was designed to evaluate the efficacy, safety, and immunogenicity of an EV71 vaccine. METHODS: We conducted a randomized, double-blind, placebo-controlled, multicenter trial in which 10,007 healthy infants and young children (6 to 35 months of age) were randomly assigned in a 1:1 ratio to receive two intramuscular doses of either EV71 vaccine or placebo, 28 days apart. The surveillance period was 12 months. The primary end point was the occurrence of EV71-associated hand, foot, and mouth disease or herpangina. RESULTS: During the 12-month surveillance period, EV71-associated disease was identified in 0.3% of vaccine recipients (13 of 5041 children) and 2.1% of placebo recipients (106 of 5028 children) in the intention-to-treat cohort. The vaccine efficacy against EV71-associated hand, foot, and mouth disease or herpangina was 94.8% (95% confidence interval [CI], 87.2 to 97.9; P<0.001) in this cohort. Vaccine efficacies against EV71-associated hospitalization (0 cases vs. 24 cases) and hand, foot, and mouth disease with neurologic complications (0 cases vs. 8 cases) were both 100% (95% CI, 83.7 to 100 and 42.6 to 100, respectively). Serious adverse events occurred in 111 of 5044 children in the vaccine group (2.2%) and 131 of 5033 children in the placebo group (2.6%). In the immunogenicity subgroup (1291 children), an anti-EV71 immune response was elicited by the two-dose vaccine series in 98.8% of participants at day 56. An anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71-associated hand, foot, and mouth disease or herpangina. CONCLUSIONS: The EV71 vaccine provided protection against EV71-associated hand, foot, and mouth disease or herpangina in infants and young children. (Funded by Sinovac Biotech; ClinicalTrials.gov number, NCT01507857.).
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cited by
Zhang, Y., Zeng, G., Pan, H., Li, C., Hu, Y., Chu, K., Han, W., Chen, Z., Tang, R., Yin, W., et al. (2021) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(20)30843-4 · Cited by 1,504
Self-citationRecommendations for enterovirus diagnostics and characterisation within and beyond Europe
Harvala, H., Broberg, E., Benschop, K., Berginc, N., Ladhani, S., Susi, P., Christiansen, C., McKenna, J., Allen, D., Makiello, P., et al. (2018) · Journal of Clinical Virology · doi:10.1016/j.jcv.2018.01.008 · Cited by 258
Enterovirus 71 infection and vaccines
Yi, E.-J., Shin, Y.-J., Kim, J.-H., Kim, T.-G., & Chang, S.-Y. (2017) · Clinical and Experimental Vaccine Research · doi:10.7774/cevr.2017.6.1.4 · Cited by 203
Enterovirus and parechovirus infection in children: a brief overview
de Crom, S. C. M., Rossen, J. W. A., van Furth, A. M., & Obihara, C. C. (2016) · European Journal of Pediatrics · doi:10.1007/s00431-016-2725-7 · Cited by 192
Metadata
- Authors
- Zhu, F., Xu, W., Xia, J., Liang, Z., Liu, Y., Zhang, X., Tan, X., Wang, L., Mao, Q., Wu, J., Hu, Y., Ji, T., Song, L., Liang, Q., Zhang, B., Gao, Q., Li, J., Wang, S., Hu, Y., Gu, S., Zhang, J., Yao, G., Gu, J., Wang, X., Zhou, Y., Chen, C., Zhang, M., Cao, M., Wang, J., Wang, H., & Wang, N.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-02-27
- Volume
- 370
- Issue
- 9
- Pages
- 818-828
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2013339538
- Cited by
- 463
- References
- 0
- FWCI
- 31.80
- Type
- journal article
- Language
- en
- Open access
- bronze
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
How to cite
Cite CoChat for the checks on this page, and the paper for its own findings.
- This page
- CoChat. (2026). Citation check: Efficacy, Safety, and Immunogenicity of an Enterovirus 71 Vaccine in China. https://app.cochat.ai/papers/10.1056/nejmoa1304923
- The paper
- Zhu, F., Xu, W., Xia, J., Liang, Z., Liu, Y., Zhang, X., Tan, X., Wang, L., Mao, Q., Wu, J., Hu, Y., Ji, T., Song, L., Liang, Q., Zhang, B., Gao, Q., Li, J., Wang, S., Hu, Y., . . . Wang, N. (2014). Efficacy, Safety, and Immunogenicity of an Enterovirus 71 Vaccine in China. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1304923
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
