A Phase IV Clinical Trial for Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71: A Multicenter， Case-control Study.
A Phase IV Clinical Trial for Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71: A Multicenter， Case-control Study.
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.
Inclusion Criteria:
For vaccination group：
For case group：
For hospital control group：
For community control group：
Exclusion Criteria:
For vaccination group：
Exclusion Criteria for the second dose:
For hospital control group：
For community control group：