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

Hand Foot and Mouth Disease Clinical Trial

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hand Foot and Mouth Disease
• Hand, Foot and Mouth Disease
• Mouth Diseases

• NCT number: NCT02889497
• Study type: Interventional
• Source: Beijing Chaoyang District Centre for Disease Control and Prevention
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 2016
• Completion date: September 2019