NCT02889497

Safety, Three Batches Consistency and Immunity Duration of the Post-marketing Inactivated Enterovirus Type 71 (EV71) Vaccine in Children Aged 6-71 Months

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20,900 (estimated)
• Sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention · Academic / Other
• Sex: All
• Age: 6 Months – 71 Months
• Healthy volunteers: Accepted

Summary

This study evaluates the safety,three batches consistency and immunity duration of the post-marketing inactivated Enterovirus Type 71 (EV71) vaccine in children aged 6-71 months.This study has two groups:safety observation group and immunogenicity observation group.20000 subjects will receive 2 doses vaccines and be observed for safety among 2 epidemic cycles of HFMD.In the immunogenicity observation group, 900 subjects will be randomly received 3 batches vaccines(2 doses),and blood sampled at days 0 and 56.

Conditions

• Hand Foot and Mouth Disease

Interventions

Type	Name	Description
BIOLOGICAL	the first batch vaccine
BIOLOGICAL	the second batch vaccine
BIOLOGICAL	the third batch vaccine

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-03-01
• Completion: 2019-09-01
• First posted: 2016-09-05
• Last updated: 2016-09-07