A Phase IV Clinical Trial for Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71: A Multicenter， Case-control Study.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hand, Foot and Mouth Disease
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Enrollment
- 40000
- Locations
- 2
- Primary Endpoint
- Odds ratio (OR) of the immunization of EV-A71 vaccine in cases vs control groups
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For vaccination group：
- •Healthy children aged 6-35 months
- •Subjects who have been clinically judged to be healthy by the researcher after being asked about the medical history and related physical examination
- •The subjects' guardians agree the requirements of the protocol and the relevant follow up visits
- •The subjects' guardians agree and sign the informed consent
- •For case group：
- •Aged from 6 to 47 months
- •Clinical diagnosis of HFMD
- •At least one throat swab or anal swab detected EV71 positive by PCR
- •The subjects' guardians agree and sign the informed consent
Exclusion Criteria
- •For vaccination group：
- •Subject who has a medical history of HFMD caused by EV71 or has been vaccinated with EV71 vaccine
- •Subject who is known to be allegric to the componets of the vaccine
- •Subject with fever or acute diseases or at acute stage of chronic diseases
- •Subject with severe chronic diseases and allergies
- •Subject with thrombocytopenia or hemorrhagic diseases
- •Subject who is receiving immunosuppressive therapy or with immunodeficiency
- •Subject with uncontrolled epilepsy and other progressive neurological illness, such as Guillain-Barre syndrome.
- •Exclusion Criteria for the second dose:
- •Have severe allergic reaction after first dose
Outcomes
Primary Outcomes
Odds ratio (OR) of the immunization of EV-A71 vaccine in cases vs control groups
Time Frame: within 12 months after completion of vaccination
Cases are defined as eligible patients who tested positive for enteroviruse 71. For each case, we will select two groups of control children, including hospital test-negative control and community control. Logistic regression is performed to calculate the odds ratio (OR) of vaccination in cases vs each of the control groups.
Secondary Outcomes
- Incidence and severity of adverse reactions/adverse events in children aged 6-35 months after EV71 vaccine receiving.(1 month after completion of vaccination)