Hand, Foot and Mouth DiseasePhase 4NCT03582761
Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71
A Phase 4 study testing EV71 vaccine in people with Hand, Foot and Mouth Disease, run by Jiangsu Province Centers for Disease Control and Prevention at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Hand, Foot and Mouth Disease
- What is being tested?
- EV71 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2019to 1 May 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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：
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- 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
Who cannot join
- 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
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- Subject who is receiving immunosuppressive therapy or with immunodeficiency
- Subject with uncontrolled epilepsy and other progressive neurological illness, such as Guillain-Barre syndrome.
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009
Hubei Provincial Center for Diseases Control and Prevention
Wuhan, Hubei, 430079
About this study
Official title: A Phase IV Clinical Trial for Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71: A Multicenter， Case-control Study.
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.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- EV71 vaccine
- Medical subject headings
- Hand, Foot and Mouth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV71 vaccineBiological
EV71 vaccine of 320U /0.5ml will be given to 40000 children aged 6-35 months old on day0,28
| Study group | Role | What they receive |
|---|---|---|
| 320U /0.5ml in children | Experimental | EV71 vaccine of 320U /0.5ml will be given to 40000 children aged 6-35 months old on day0,28 Receives: Biological: EV71 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 12 months after completion of vaccination
Secondary outcomes (1)
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.
Measured: 1 month after completion of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start1 May 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand, Foot and Mouth DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Wuhan Institute of Biological Products Co., Ltd, Hubei Provincial Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Zhu Feng-Cai, Master, Principal investigator, Jiangsu Provincial Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582761
- Sponsor's protocol ID
- JSVCT048
- Status last verified
- May 2019
- First submitted
- 8 Jun 2018
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcomes will be made available within 6 months of study completion.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Clinical Trial for Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71: A Multicenter， Case-control Study.
- ClinicalTrials.gov ID
- NCT03582761
- Acronym / sponsor ID
- JSVCT048
- Conditions
- Hand, Foot and Mouth Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40,000 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Wuhan Institute of Biological Products Co., Ltd, Hubei Provincial Center for Disease Control and Prevention
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 320U /0.5ml in children | Experimental | Biological: EV71 vaccineEV71 vaccine of 320U /0.5ml will be given to 40000 children aged 6-35 months old on day0,28 |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EV71 vaccineEV71 vaccine of 320U /0.5ml will be given to 40000 children aged 6-35 months old on day0,28 | Biological | 320U /0.5ml in children |
Primary outcome
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.
1 secondary outcome
Incidence and severity of adverse reactions/adverse events in children aged 6-35 months after EV71 vaccine receiving.
Time frame: 1 month after completion of vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcomes will be made available within 6 months of study completion.
Related trials for Hand, Foot and Mouth Disease
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CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu
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Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children
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Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
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Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine
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Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhu Feng-Cai, Master principal investigator
Jiangsu Provincial Center for Diseases Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EV71 vaccine in people with Hand, Foot and Mouth Disease, run by Jiangsu Province Centers for Disease Control and Prevention at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odds ratio (OR) of the immunization of EV-A71 vaccine in cases vs control groups (time frame: within 12 months after completion of vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.