NCT03582761

Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71

A Phase IV Clinical Trial for Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71: A Multicenter， Case-control Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40,000 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

Summary

This study is a multicenter, case-control phase IV clinical trial to evaluate the effectiveness of the EV71 vaccine. About 40000 children in the town aged 6-35 months will be recruited and vaccinated with EV71 vaccines, which account for 20-40% of the children aged 6-35 months in the areas. The subjects will be vaccinated with EV71 vaccine at day 0 and day 28. Other children of appropriate age in the town will choose voluntarily whether or not to be vaccinated with EV71 vaccine. All children's vaccination of EV71 vaccines will be recorded in the study areas and the coverage rate of EV71 vaccine in the town will be calculated. The vaccination is expected to complete before the epidemic peak of HFMD. Surveillance of HFMD cases caused by EV71 will be conducted in hospitals of the study areas for 10-12 months, which cover a whole HFMD epidemic period. Throat and anal swabs will be collected from children with a clinically diagnosed HFMD for typing of human enteroviruses tested by PCR. The HFMD cases with EV71 positive will be recruited as cases, while those with EV71 negative will be recruited as test-negative controls. Besides, for each EV71-associated HFMD cases, the investigators will select 4 community controls mateced with each case for age, sex and residence.

Conditions

• Hand, Foot and Mouth Disease

Interventions

Type	Name	Description
BIOLOGICAL	EV71 vaccine	EV71 vaccine of 320U /0.5ml will be given to 40000 children aged 6-35 months old on day0,28

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2018-07-11
• Last updated: 2021-05-24

Locations

2 sites across 1 country: China