Hand, Foot and Mouth Disease
Conditions
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.
Interventions
BIOLOGICALEV71 vaccine
EV71 vaccine of 320U /0.5ml will be given to 40000 children aged 6-35 months old on day0,28
Sponsors
Wuhan Institute of Biological Products Co., Ltd
Hubei Provincial Center for Disease Control and Prevention
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
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 For hospital control group： * Aged from 6 to 47 months * Clinical diagnosis of HFMD * Throat swabs or anal swabs are positive for enterovirus and negative for EV71 * The subjects' guardians agree and sign the informed consent For community control group： * Aged from 6 to 47 months * No clinically diagnosed HFMDs, and no fever, HFMD suspected symptoms, such as hand, foot and mouth herpes * The same gender as the matched case * The age is similar to that of matched case (for cases ≥ 12 months of age, the age difference is within ±3 months, for case \< 12 months of age, the age difference is within ±30 days) * Near the residence of the case (the same village or adjacent village) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Odds ratio (OR) of the immunization of EV-A71 vaccine in cases vs control groups | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse reactions/adverse events in children aged 6-35 months after EV71 vaccine receiving. | 1 month after completion of vaccination | Incidence and severity of adverse reactions/adverse events in children aged 6-35 months within 1 month after completion of vaccination. |
Countries
China
Outcome results
None listed