Who Universal Trial Numbers (utns): U1111-1174-4615 and U1111-1174-4698.
Clinicaltrials.gov: NCT04210349 and NCT03430089.
Background: The Sinovac enterovirus 71 (EV71) vaccine has been given to children aged 6-35 months with good safety, immunogenicity, and efficacy. Further exploration is needed for the application of Sinovac EV71 vaccine in older children.
Methods: A phase III, double-blind, single-center, randomized, controlled, non-inferiority, and bridging-designed trial enrolled 300 participants aged 6-35 months and 600 participants aged 36-71 months.