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Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71

Primary Purpose

Hand, Foot and Mouth Disease

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

EV71 vaccine

About this trial

This is an interventional prevention trial for Hand, Foot and Mouth Disease

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts 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：

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

Sites / Locations

Hubei Provincial Center for Diseases Control and Prevention
Jiangsu Provincial Center for Diseases Control and Prevention

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

320U /0.5ml in children

Arm Description

EV71 vaccine of 320U /0.5ml will be given to 40000 children aged 6-35 months old on day0,28

Outcomes

Primary Outcome Measures

Odds ratio (OR) of the immunization of EV-A71 vaccine in cases vs control groups

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 Outcome Measures

Incidence and severity of adverse reactions/adverse events in children aged 6-35 months after EV71 vaccine receiving.

Incidence and severity of adverse reactions/adverse events in children aged 6-35 months within 1 month after completion of vaccination.

Full Information

NCT ID

NCT03582761

First Posted

June 8, 2018

Last Updated

May 21, 2021

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Collaborators

Wuhan Institute of Biological Products Co., Ltd, Hubei Provincial Center for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT03582761

Brief Title

Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71

Official Title

A Phase IV Clinical Trial for Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71: A Multicenter， Case-control Study.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

May 1, 2020 (Actual)

Study Completion Date

May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Collaborators

Wuhan Institute of Biological Products Co., Ltd, Hubei Provincial Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hand, Foot and Mouth Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40000 (Actual)

8. Arms, Groups, and Interventions

Arm Title

320U /0.5ml in children

Arm Type

Experimental

Arm Description

EV71 vaccine of 320U /0.5ml will be given to 40000 children aged 6-35 months old on day0,28

Intervention Type

Biological

Intervention Name(s)

EV71 vaccine

Intervention Description

EV71 vaccine of 320U /0.5ml will be given to 40000 children aged 6-35 months old on day0,28

Primary Outcome Measure Information:

Title

Odds ratio (OR) of the immunization of EV-A71 vaccine in cases vs control groups

Description

Time Frame

within 12 months after completion of vaccination

Secondary Outcome Measure Information:

Title

Incidence and severity of adverse reactions/adverse events in children aged 6-35 months after EV71 vaccine receiving.

Description

Incidence and severity of adverse reactions/adverse events in children aged 6-35 months within 1 month after completion of vaccination.

Time Frame

1 month after completion of vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

35 Months

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhu Feng-Cai, Master

Organizational Affiliation

Jiangsu Provincial Center for Diseases Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hubei Provincial Center for Diseases Control and Prevention

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430079

Country

China

Facility Name

Jiangsu Provincial Center for Diseases Control and Prevention

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual participant data for all primary and secondary outcomes will be made available within 6 months of study completion.

IPD Sharing Time Frame

Data will be available within 6 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by the sponsor. Requestors will be required to sign a Date Access Agreement.

Learn more about this trial

Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71

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