Efficacy, Safety, and Immunogenicity of an Enterovirus 71 Vaccine in China
New England Journal of Medicine·
- DOI
- 10.1056/nejmoa1304923
- PMID
- 24571754
- PMCID
- —
- OpenAlex
- W2013339538
- Study type
- Randomised controlled trial
- Publisher
- Massachusetts Medical Society
- Article type
- journal-article
- Integrity
- current
Why this research matters now
The trial addresses EV71, identified in the abstract as a major cause of outbreaks of hand, foot, and mouth disease and herpangina, in a large pediatric population in China.
Structured evidence summary
Research question
Whether an EV71 vaccine protects infants and young children against EV71-associated hand, foot, and mouth disease or herpangina.
Study design
Randomized, double-blind, placebo-controlled, multicenter phase 3 trial with 1:1 allocation, two intramuscular doses 28 days apart, and 12-month surveillance.
Population and setting
10,007 healthy infants and young children aged 6 to 35 months enrolled in China.
Main findings
EV71-associated disease occurred in 0.3% of vaccine recipients versus 2.1% of placebo recipients over 12 months, with reported vaccine efficacy of 94.8% (95% CI 87.2 to 97.9) against EV71-associated hand, foot, and mouth disease or herpangina. The abstract also notes that the safety and immunogenicity profile was evaluated, with the reported conclusion stating that the vaccine provided protection in this population.
Public-health relevance
The trial addresses EV71, identified in the abstract as a major cause of outbreaks of hand, foot, and mouth disease and herpangina, in a large pediatric population in China.
Important limitations
The supplied abstract does not enumerate explicit study limitations. Accordingly, this summary is limited to the supplied single-article abstract and metadata and would require the original paper for decision-grade interpretation.
GIDS interpretation
The paper is indexed under hand, foot, and mouth disease/herpangina, vaccination, vaccine effectiveness, surveillance, and treatment in China, which may aid discoverability for reviewers tracking EV71-related evidence; no connection to a live surveillance signal is made here.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 13 auditable classifier relationships to diseases, places, topics, and study design.