A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children

Summary

The objectives of this study are to evaluate the EV71vaccine efficacy, immune response and safety profiles after two injections of the cell culture-based inactivated EV71 vaccine with adjuvant Al(OH)3 administrated in pediatric population aged 2 months to 6 years old.

Timeline

Start

2018-06-27

Primary completion

2024-08-30

Completion

2024-12-31

Outcome

Met primary endpoint

paper 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). PMID 41680199 ↗

Publications

• Hwang KP, Luong QC, Huang YC, Lai CC, Le PH, Thi Tran MT, Tan BF, Chen PY, Yang SC, Liu WT, Thao NTT, Lee P, Lin ST, Liu CC, Chen CC, Yang CF, Huang LM. A randomised trial of a bioreactor-produced EV-A71 vaccine for endemic control in children. NPJ Vaccines. 2026 Feb 12;11(1):65. doi: 10.1038/s41541-026-01396-x.

Drugs

Indications