Hand, Foot and Mouth DiseasePhase 4NCT03903926

Efficacy Trial of a Commercial EV71 Vaccine

A Phase 4 study testing 5000 volunteers (6-35 months)-EV71 vaccine in people with Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this post-marketing study is to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine post marketing, and explore the protective levels of various enterovirus neutralizing antibodies Read more about this study

Who is it for?: Ages 6 to 71 monthsHealthy volunteers can take part
Conditions the study is for: Hand, Foot and Mouth Disease
What is being tested?: 5000 volunteers (6-35 months)-EV71 vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15,500 participants
Where: 2 sitesChina
Study dates: 26 Mar 2019to 30 Oct 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 71 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Volunteers aged 6-71 months;
Guardians of the participants voluntarily to vaccinate the participants with EV71 vaccine at their own expense;
Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrollment;
Complying with the requirement of the study protocol;

Who cannot join

History of HFMD prior to the study entry;
Prior vaccination with EV71 vaccine;
History of allergy to any vaccine, or any ingredient, excipients and Gentamycin Sulfate of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc. (only for 6-35 months old subjects of the vaccinated group) ;
Congenital malformation, developmental disorders, genetic defects, or severe malnutrition (only for 6-35 months old subjects of the vaccinated group);
Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness (only for 6-35 months old subjects of the vaccinated group);
Autoimmune disease or immunodeficiency/immunosuppressive (only for 6-35 months old subjects of the vaccinated group) ;

Show all 10Show fewer

History of asthma, angioedema, diabetes or malignancy (only for 6-35 months old subjects of the vaccinated group);
Acute disease or acute stage of chronic disease within 7 days prior to study entry (only for 6-35 months old subjects of the vaccinated group);
Axillary temperature > 37.0 Celsius (only for 6-35 months old subjects of the vaccinated group)；
Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Songzi Center for Disease Control and Prevention
Jingzhou, Hubei, 434200
Xiantao Center for Disease Control and Prevention
Xiantao, Hubei, 433000

Other trials in China

About this study

Official title: Phase Ⅳ Clinical Trial, to Evaluate the Efficacy of the Enterovirus 71 (EV71) Inactivated Vaccine and Its Correlation With EV71 Antibody Level

Read the detailed description

This study is a post-marketing aims to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine, and explore the protective levels of various enterovirus neutralizing antibodies. This study includes the following three sections: (1) efficacy study of EV71 vaccine based on enhanced cases monitoring, using prospective cohort study design (2) study on correlation between EV71 vaccine protection and EV71 antibody levels, using case-control study design (3) pathogenic spectrum and sero-epidemiological investigation of hand, foot and mouth disease (HFMD) in children. 15500 volunteers aged 6-71 months are expected to participate in this study, among which 5000 volunteers aged 6-35 months will receive two doses EV71 vaccine manufactured by Sinovac Biotech Co., Ltd, and constitute the experimental cohort. 10000 unvaccinated volunteers aged 6-35 months will constitute the the control cohort. The efficacy evaluation will be conducted based on the abovementioned two cohort. Enhanced HFMD surveillance system will be established to report the HFMD cases in the abovementioned 2 cohorts, as well as another cohort consisting of 500 volunteers aged 36-71 months. The case surveillance period of this study is one year. Laboratory tests will be conducted for case confirmation.

Conditions: Hand, Foot and Mouth Disease
Being tested: 5000 volunteers (6-35 months)-EV71 vaccine
Keywords: EV71 vaccine; Efficacy; Seroprotective correlates
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.

5000 volunteers (6-35 months)-EV71 vaccineBiological
two doses EV71 vaccines will be administrated on day 0, 30 respectively

Study groups in NCT03903926
Study group	Role	What they receive
Cohort one	Experimental	5000 volunteers (6-35 months)-EV71 vaccine Receives: Biological: 5000 volunteers (6-35 months)-EV71 vaccine
Cohort two	No intervention	10000 unvaccinated volunteers (6-35 months)
Cohort three	No intervention	500 unvaccinated volunteers (36-71 months)

What is being measured

The primary outcome is the main question the study is designed to answer.

The efficacy of two doses EV71 vaccine in the 6-35 months old subjects
Vaccine Efficacy (VE)=(incidence difference between vaccinated and unvaccinated group/incidence of vaccinated group)*100%
Measured: During the case monitoring period of 1 year
The seroprotective titers of the EV71 neutralizing antibody in the 6-35 months old subjects
Immune correlates of protection
Measured: Through study completion, an average of 1 year

Secondary outcomes (7)

The incidence of adverse events after the EV71 vaccination in the 6-35 months old subjects
Safety index
Measured: Within 6 months after each dose injection
The seroprotective titers of the CA16, CA6, CA10 neutralizing antibody in the 6-35 months old subjects
Immune correlates of protection
Measured: Through study completion, an average of 1 year
The seropositive rate of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects
Serum epidemiological index
Measured: During the study period, 2 months after the study beginning
The geometric mean titer (GMT) of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects
Serum epidemiological index
Measured: During the study period, 2 months after the study beginning
The seroconversion rate of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects
Immunogenicity index
Measured: 30 days after two doses
The geometric mean increase (GMI) of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects
Immunogenicity index
Measured: 30 days after two doses
Proportions of various pathogens in the confirmed HFMD cases
Pathogen spectrum index
Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 201930 Oct 2020

First posted4 Apr 2019
Study start26 Mar 2019
Primary completion30 Jun 2020
Study completion30 Oct 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.
More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 15,500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03903926
Sponsor's protocol ID: PRO-EV71-4013
Status last verified: Jul 2021
First submitted: 29 Mar 2019
Last updated: 27 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu
Hand, Foot and Mouth Disease, Infection Control
Not yet recruiting
Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children
Hand, Foot, and Mouth Disease (HFMD), Enterovirus 71 Infection
Not yet recruitingPhase 3
Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
Hand, Foot, and Mouth Disease(HFMD), Herpangina
Not yet recruitingPhase 1
Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine
Hand, Foot and Mouth Disease (HFMD), HFMD
Enrolling by invitationObservational study
Study on the Persistence of Immunity Following EV71 Vaccination
Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD)

All Hand, Foot and Mouth Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase Ⅳ Clinical Trial, to Evaluate the Efficacy of the Enterovirus 71 (EV71) Inactivated Vaccine and Its Correlation With EV71 Antibody Level
ClinicalTrials.gov ID: NCT03903926
Acronym / sponsor ID: PRO-EV71-4013
Conditions: Hand, Foot and Mouth Disease
Keywords: EV71 vaccine; Efficacy; Seroprotective correlates
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 15,500 participants (actual)
Lead sponsor: Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
Study start: 26 Mar 2019 (actual)
Primary completion: 30 Jun 2020 (actual)
Study completion: 30 Oct 2020 (actual)
First posted: 4 Apr 2019 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort one	Experimental	Biological: 5000 volunteers (6-35 months)-EV71 vaccine5000 volunteers (6-35 months)-EV71 vaccine
Cohort two	No intervention	–10000 unvaccinated volunteers (6-35 months)
Cohort three	No intervention	–500 unvaccinated volunteers (36-71 months)

Who may qualify

Ages: 6 to 71 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Volunteers aged 6-71 months;
Guardians of the participants voluntarily to vaccinate the participants with EV71 vaccine at their own expense;
Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrollment;
Complying with the requirement of the study protocol;

Key exclusion criteria (10 listed)

History of HFMD prior to the study entry;
Prior vaccination with EV71 vaccine;
History of allergy to any vaccine, or any ingredient, excipients and Gentamycin Sulfate of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc. (only for 6-35 months old subjects of the vaccinated group) ;
Congenital malformation, developmental disorders, genetic defects, or severe malnutrition (only for 6-35 months old subjects of the vaccinated group);
Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness (only for 6-35 months old subjects of the vaccinated group);

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
5000 volunteers (6-35 months)-EV71 vaccinetwo doses EV71 vaccines will be administrated on day 0, 30 respectively	Biological	Cohort one

Primary outcome

The efficacy of two doses EV71 vaccine in the 6-35 months old subjects
Time frame: During the case monitoring period of 1 year
Vaccine Efficacy (VE)=(incidence difference between vaccinated and unvaccinated group/incidence of vaccinated group)*100%
The seroprotective titers of the EV71 neutralizing antibody in the 6-35 months old subjects
Time frame: Through study completion, an average of 1 year
Immune correlates of protection

7 secondary outcomes

The incidence of adverse events after the EV71 vaccination in the 6-35 months old subjects
Time frame: Within 6 months after each dose injection
The seroprotective titers of the CA16, CA6, CA10 neutralizing antibody in the 6-35 months old subjects
Time frame: Through study completion, an average of 1 year
The seropositive rate of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects
Time frame: During the study period, 2 months after the study beginning
The geometric mean titer (GMT) of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects
Time frame: During the study period, 2 months after the study beginning
The seroconversion rate of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects
Time frame: 30 days after two doses
The geometric mean increase (GMI) of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects
Time frame: 30 days after two doses
Proportions of various pathogens in the confirmed HFMD cases
Time frame: Through study completion, an average of 1 year

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 27 Jul 2021.

Related trials for Hand, Foot and Mouth Disease

Not yet recruiting
CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu
Hand, Foot and Mouth Disease, Infection Control
Not yet recruiting
Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children
Hand, Foot, and Mouth Disease (HFMD), Enterovirus 71 Infection
Not yet recruitingPhase 3
Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
Hand, Foot, and Mouth Disease(HFMD), Herpangina
Not yet recruitingPhase 1
Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine
Hand, Foot and Mouth Disease (HFMD), HFMD
Enrolling by invitationObservational study
Study on the Persistence of Immunity Following EV71 Vaccination
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.

Xuhua Guan, Doctor principal investigator

Hubei Provincial Center for Disease 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 5000 volunteers (6-35 months)-EV71 vaccine in people with Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd 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 4 inclusion and 10 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 27 Jul 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?

The efficacy of two doses EV71 vaccine in the 6-35 months old subjects (time frame: During the case monitoring period of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03903926.

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 27 Jul 2021.