Hand, Foot and Mouth DiseasePhase 4NCT04111432

Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines

A Phase 4 study testing Concomitant administration of EV71vaccine with EPI vaccines, Single injection of EPI vaccine and EV71 Vaccine only in people with Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd at 1 site 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 study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with measles mumps, and rubella combined live attenuated vaccine/ encephalitis live attenuated vaccine. Read more about this study

Who is it for?: Ages 8 months and olderHealthy volunteers can take part
Conditions the study is for: Hand, Foot and Mouth Disease
What is being tested?: Concomitant administration of EV71vaccine with EPI vaccines, Single injection of EPI vaccine and EV71 Vaccine only
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 372 participants
Where: 1 siteChina
Study dates: 26 Jul 2019to 25 Mar 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 8 months and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Healthy volunteer aged ≥ 8 months;
Proven legal identity;
Guardians of the participants should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study.

Who cannot join

Prior vaccination with EV71 vaccine;
Prior vaccination with MMR vaccine or vaccine including mumps or measles or mumps or rubella vaccine components;
Prior vaccination with Encephalitis B vaccine；
Cannot be vaccinated with both arms at the same time；
History of hand，foot and mouth disease;
History of measles or mumps or rubella or encephalitis B；

Show all 21Show fewer

Allergy to gentamicin; history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria,difficulty in breathing, angioneurotic edema, pain, etc;
Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
Autoimmune diseases or immunodeficiency/immunosuppression;
Severe neurological disorders (epilepsy, convulsions or convulsions) or psychosis;
History of thyroidectomy, absence of spleen, functional absence of spleen, and any circumstances leading to absence of spleen or splenectomy;
Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) in the past 6 months;
Receipt of any of the following products:
Blood product within 3 months prior to study entry;
Any live attenuated vaccine within 14 days prior to study entry;
Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
Any other study drugs within 30 days prior to study entry;
Acute disease or acute stage of chronic disease within 7 days prior to study entry;
Axillary temperature > 37.0#;
Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

Hanbin District Center for Disease Control and Prevention
Ankang, Shaanxi, 725000

Other trials in China

About this study

Official title: A Randomized, Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Measles, Mumps, and Rubella Combined Live Attenuated Vaccine/ Encephalitis Live Attenuated Vaccine

Read the detailed description

This study is an open-label, single-center, randomized, comparative phase IV clinical trial. The purpose of this study is to evaluate the safety andimmunogenicity of concomitant administration of EV71 vaccine manufactured by Sinovac (Beijing) Vaccine Technology Co., Ltd. with measles mumps, and rubella combined live attenuated vaccine/ encephalitis live attenuated vaccine. 360 healthy infants of 8 months old as participants are randomly assigned into three experimental groups in the ratio 1:1:1. The group I receive EV71 Vaccine (first dose)\&measles mumps, and rubella combined live attenuated vaccine on day 0 and EV71 vaccine (second dose)\&encephalitis live attenuated vaccine on day 30. The group II receive measles mumps, and rubella combined live attenuated vaccine on day 0 and encephalitis live attenuated vaccine on day 30. The group III receive the first and second dose of EV71 Vaccine on day 0 and day 30 respectively.

Conditions: Hand, Foot and Mouth Disease
Being tested: Concomitant administration of EV71vaccine with EPI vaccines, Single injection of EPI vaccine, EV71 Vaccine only
Keywords: Inactivated Enterovirus Type 71 (EV71) Vaccine, Concomitant vaccination, Safety, Immunogenicity, Infant
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.

Concomitant administration of EV71vaccine with EPI vaccinesBiological
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.# the MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.
Single injection of EPI vaccineBiological
The MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.
EV71 Vaccine onlyBiological
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.

Study groups in NCT04111432
Study group	Role	What they receive
Group I-EV71 and EPI vaccines Concomitant administration	Experimental	EV71 Vaccine (intramuscular injection,0.5ml,first dose)/measles mumps, and rubella combined live attenuated vaccine (subcutaneous injection,0.5ml) on day 0 and EV71 Vaccine (intramuscular injection, 0.5ml,second dose)/ encephalitis live attenuated vaccine (subcutaneous injection, 0.5ml) on day 30 Receives: Biological: Concomitant administration of EV71vaccine with EPI vaccines
Group II-EPI vaccine only Single injection of EPI vaccine:	Active comparator	measles mumps, and rubella combined live attenuated vaccine (subcutaneous injection,0.5ml) on day 0 and encephalitis live attenuated vaccine (subcutaneous injection, 0.5ml) on day 30 Receives: Biological: Single injection of EPI vaccine
Group III-EV71 vaccine only EV71 Vaccine only	Active comparator	the first and second dose of EV71 Vaccine (intramuscular injection,0.5ml) on day 0 andday 30 respectively Receives: Biological: EV71 Vaccine only

What is being measured

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

The seroconversion rates（SCR） of the EV71 neutralizing antibody 30 days after two dose of EV71 vaccines
Immunogenicity indicator
Measured: 30 days after two dose of EV71 vaccines

Secondary outcomes (11)

The seroconversion rates（SCR） of the Measles IgG antibody，Rubella 30 IgG antibody and Mumps IgG antibody 60 days after one dose of MMR vaccine
Immunogenicity indicator
Measured: 60 days after one dose of MMR vaccine
The seroconversion rates（SCR） of the Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine
Immunogenicity indicator
Measured: 30 days after one dose of Encephalitis B vaccine
EV71 neutralizing antibody positive rate 30 days of two dose of EV71 vaccines
Immunogenicity indicator
Measured: 30 days after two dose of EV71 vaccines
The Geometric mean titer (GMT) of the EV71 neutralizing antibody 30 days of two dose of EV71 vaccines
Immunogenicity indicator
Measured: 30 days after two dose of EV71 vaccines
Measles IgG antibody，Rubella 30 IgG antibody and Mumps IgG antibody positive rate 60 days after one dose of MMR vaccine
Immunogenicity indicator
Measured: 60 days after one dose of MMR vaccine
The Geometric mean titer (GMT) of Measles IgG antibody，Rubella 30 IgG antibody and Mumps IgG antibody 60 days after one dose of MMR vaccine
Immunogenicity indicator
Measured: 60 days after one dose of MMR vaccine
The Japanese encephalitis neutralizing antibody positive rate 30 days after one dose of Encephalitis B vaccine
Immunogenicity indicator
Measured: 30 days after one dose of Encephalitis B vaccine
The Geometric mean titer (GMT) of Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine
Immunogenicity indicator
Measured: 30 days after one dose of Encephalitis B vaccine
Incidence of solicited local or systemic adverse events within 7 days or 14 days after each dose
Safety indicator
Measured: 7 days or 14 days after each dose of injection
The incidences of adverse reactions after each does
After each dose, a 30-minute safety observation will be conducted immediately. The body temperature, solicited local and general adverse events (AE) on day 0-7 or day 0-14 were reported. Unsolicited adverse events on day 0-30 were also reported.
Measured: 0-30 days after each dose
Incidence of serious adverse events (SAEs) during the period of safety monitoring
Serious adverse events (SAEs) will be collected during the period of safety monitoring after each dose
Measured: 0-30 days after each dose

Timeline

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

26 Jul 201925 Mar 2020

First posted1 Oct 2019
Study start26 Jul 2019
Primary completion25 Nov 2019
Study completion25 Mar 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 372 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04111432
Sponsor's protocol ID: EV71-SN-2019-01
Status last verified: Jul 2021
First submitted: 29 Sep 2019
Last updated: 29 Jul 2021
Results posted: 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 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Measles, Mumps, and Rubella Combined Live Attenuated Vaccine/ Encephalitis Live Attenuated Vaccine
ClinicalTrials.gov ID: NCT04111432
Acronym / sponsor ID: EV71-SN-2019-01
Conditions: Hand, Foot and Mouth Disease
Keywords: Inactivated Enterovirus Type 71 (EV71) Vaccine, Concomitant vaccination, Safety, Immunogenicity, Infant
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 372 participants (actual)
Lead sponsor: Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
Collaborators: Shaanxi Provincial Center for Disease Control and Prevention
Study start: 26 Jul 2019 (actual)
Primary completion: 25 Nov 2019 (actual)
Study completion: 25 Mar 2020 (actual)
First posted: 1 Oct 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group I-EV71 and EPI vaccines Concomitant administration	Experimental	Biological: Concomitant administration of EV71vaccine with EPI vaccinesEV71 Vaccine (intramuscular injection,0.5ml,first dose)/measles mumps, and rubella combined live attenuated vaccine (subcutaneous injection,0.5ml) on day 0 and EV71 Vaccine (intramuscular injection, 0.5ml,second dose)/ encephalitis live attenuated vaccine (subcutaneous injection, 0.5ml) on day 30
Group II-EPI vaccine only Single injection of EPI vaccine:	Active comparator	Biological: Single injection of EPI vaccinemeasles mumps, and rubella combined live attenuated vaccine (subcutaneous injection,0.5ml) on day 0 and encephalitis live attenuated vaccine (subcutaneous injection, 0.5ml) on day 30
Group III-EV71 vaccine only EV71 Vaccine only	Active comparator	Biological: EV71 Vaccine onlythe first and second dose of EV71 Vaccine (intramuscular injection,0.5ml) on day 0 andday 30 respectively

Who may qualify

Ages: 8 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Healthy volunteer aged ≥ 8 months;
Proven legal identity;
Guardians of the participants should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study.

Key exclusion criteria (21 listed)

Prior vaccination with EV71 vaccine;
Prior vaccination with MMR vaccine or vaccine including mumps or measles or mumps or rubella vaccine components;
Prior vaccination with Encephalitis B vaccine；
Cannot be vaccinated with both arms at the same time；
History of hand，foot and mouth disease;

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
Concomitant administration of EV71vaccine with EPI vaccinesThe investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.# the MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.	Biological	Group I-EV71 and EPI vaccines Concomitant administration
Single injection of EPI vaccineThe MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.	Biological	Group II-EPI vaccine only Single injection of EPI vaccine:
EV71 Vaccine onlyThe investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.	Biological	Group III-EV71 vaccine only EV71 Vaccine only

Primary outcome

The seroconversion rates（SCR） of the EV71 neutralizing antibody 30 days after two dose of EV71 vaccines
Time frame: 30 days after two dose of EV71 vaccines
Immunogenicity indicator

11 secondary outcomes

The seroconversion rates（SCR） of the Measles IgG antibody，Rubella 30 IgG antibody and Mumps IgG antibody 60 days after one dose of MMR vaccine
Time frame: 60 days after one dose of MMR vaccine
The seroconversion rates（SCR） of the Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine
Time frame: 30 days after one dose of Encephalitis B vaccine
EV71 neutralizing antibody positive rate 30 days of two dose of EV71 vaccines
Time frame: 30 days after two dose of EV71 vaccines
The Geometric mean titer (GMT) of the EV71 neutralizing antibody 30 days of two dose of EV71 vaccines
Time frame: 30 days after two dose of EV71 vaccines
Measles IgG antibody，Rubella 30 IgG antibody and Mumps IgG antibody positive rate 60 days after one dose of MMR vaccine
Time frame: 60 days after one dose of MMR vaccine
The Geometric mean titer (GMT) of Measles IgG antibody，Rubella 30 IgG antibody and Mumps IgG antibody 60 days after one dose of MMR vaccine
Time frame: 60 days after one dose of MMR vaccine
The Japanese encephalitis neutralizing antibody positive rate 30 days after one dose of Encephalitis B vaccine
Time frame: 30 days after one dose of Encephalitis B vaccine
The Geometric mean titer (GMT) of Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine
Time frame: 30 days after one dose of Encephalitis B vaccine
Incidence of solicited local or systemic adverse events within 7 days or 14 days after each dose
Time frame: 7 days or 14 days after each dose of injection
The incidences of adverse reactions after each does
Time frame: 0-30 days after each dose
Incidence of serious adverse events (SAEs) during the period of safety monitoring
Time frame: 0-30 days after each dose

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 29 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.

Shaobai Zhang principal investigator

Shaanxi Provincal Center for Disease Control and Preventione

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 21 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 29 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 1 site 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 seroconversion rates（SCR） of the EV71 neutralizing antibody 30 days after two dose of EV71 vaccines (time frame: 30 days after two dose of EV71 vaccines). 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 NCT04111432.

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 29 Jul 2021.