NCT07026500

Clinical Trial for Batch Consistency of EV71 Vaccine

A Single-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Batch Consistency of the EV71 Vaccine in Infants Aged 6 to 35 Months After Vaccination According to a Two-dose Immunization Schedule

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 720 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

Summary

This trial is designed as a single-center, randomized, double-blind study. A total of 720 infants aged 6 to 35 months are selected (with 240 subjects in each age group: 6-11 months, 12-23 months, and 24-35 months). Subjects from different age groups are randomly allocated to three batch groups in a 1:1:1 ratio, and receive two doses of the EV71 vaccine from the commercial production batch on days 0 and 30. After each vaccination dose, subjects will be observed for immediate reactions for 30 minutes and for solicited adverse events for the next 7 days, as well as for unsolicited adverse events over the 30 days following vaccination. All subjects will have blood samples collected on day 0 (pre-immunization) and day 60 for serum antibody testing. Additionally, 270 subjects will be selected, for additional blood sampling at various time points: 7 days, 14 days, and 30 days after the first dose, and 7 days and 14 days after the second dose, to assess the EV71 antibody levels at different timepoints following various doses of vaccination.

Conditions

• EV71 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	EV71 Vaccine	EV71 vaccine of commercial production batch

Timeline

• Start date: 2019-09-19
• Primary completion: 2020-04-30
• Completion: 2020-05-31
• First posted: 2025-06-18
• Last updated: 2025-06-18

Locations

1 site across 1 country: China