Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71

Jiangsu Provincial Center for Disease Control and Prevention

Status and phase

Completed

Phase 4

Conditions

Hand, Foot and Mouth Disease

Treatments

Biological: EV71 vaccine

Study type

Interventional

Funder types

Other

NETWORK

Industry

Identifiers

NCT03582761

JSVCT048

Details and patient eligibility

About

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.

Enrollment

40,000 patients

Sex

All

Ages

6 to 35 months old

Volunteers

Accepts Healthy Volunteers

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：