Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-24 @ 11:58 AM
NCT ID:
NCT03582761
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
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.
Exclusion Criteria for the second dose:
* Have severe allergic reaction after first dose
* Have severe adverse reactions related to first dose
* Any situation meet the exclusion criteria stated in the exclusion criteria for first dose
* Acute infection or illness
* Other factors that are not suitable for clinical trials according to the judgment of researchers For case group：
* Unknown of EV71 vaccination history
* EV71 related disease occurred within 28 days after the first vaccination
* The place of residence is not included in the study areas
For hospital control group：
* Unknown of EV71 vaccination history
* A history of HFMD caused by EV71 or unknown HFMD related pathogen
* The place of residence is not included in the study areas
* For community control group：
* For community control group：
For community control group：
* Unknown of EV71 vaccination history
* A history of HFMD caused by EV71 or unknown HFMD related pathogen
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
35 Months
Study:
NCT03582761
Study Brief:
Protocol Section:
NCT03582761