Hand, Foot and Mouth DiseasePhase 4NCT05397587
An Immunity Persistence Study of Enterovirus 71 Inactivated Vaccine (Vero Cell)
A Phase 4 study testing Experimental Vaccine in people with Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
This is an open，observational and follow-up clinical trial based on the clinical trial of EV71 vaccine extended age group.The purpose of this study is to evaluate the immunity persistence of EV71 vaccine developed by Sinovac Biotech Co., Ltd in subjects aged 6 ~71 months after full immunization of two doses of vaccine. 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?
- Experimental Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2022to 30 Oct 2025
- 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
- Subjects in the EV71 vaccine extended age clinical trial who received two doses of experimental or control vaccine and were enrolled in the PPS set;
- Provide legal identification;
- Participants or guardians of the participants should be capable of understanding the written consent form and voluntarily participate in the clinical trial.
Who cannot join
- Vaccination history of vaccines containing EV71 antigen components other than the EV71 vaccine expanded age group clinical trial;
- History of hand, foot and mouth disease caused EV71;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Yun County Center for Disease Control and Prevention
Lincang, Yunnan, 675800
Yuncong Li, 18288351142, 908038397@qq.com
About this study
Official title: An Open, Observational Study to Evaluate the Immunity Persistence of an Inactivated Enterovirus 71 Vaccine (Vero Cell) in Subjects Aged 6 to 71 Months
This is an open，observational and follow-up clinical trial based on the clinical trial of EV71 vaccine extended age group.The purpose of this study is to evaluate the immunity persistence of EV71 vaccine developed by Sinovac Biotech Co., Ltd in subjects aged 6 ~71 months after full immunization of two doses of vaccine.
Read the detailed description
This study is an open,observational and follow-up clinical trial of EV71 vaccine based on the clinical trial of EV71 vaccine extended age group.The main purpose of this study is to evaluate the immunity persistence of EV71 vaccine developed by Sinovac Biotech Co., Ltd in subjects aged 6~71 months after full immunization of two doses of vaccine.In this study, a total of 474 subjects from the EV71 vaccine extended age clinical trial who received two doses of experimental or control vaccine and were enrolled in the PPS set，including 274 subjects aged 6~35 months (the maximum number of subjects aged 6-23 months is 146, and the maximum number of subjects aged 24-35 months is 128),100 subjects aged 36~71 months and were enrolled in experimental group(EV71 vaccine developed by Sinovac Biotech Co., Ltd) and 100 subjects aged 36~71 months and were enrolled in control group(EV71 vaccine developed by Institute of Medical Biology,Chinese Academy of Medical Sciences) will be enrolled .Blood samples will be collected from subjects aged 6-23 months at 36 months after full immunization and at the age of 72 months.Blood samples will be collected from subjects aged 24 to 35 months at 36 months after full immunization.Blood samples will be collected from subjects aged 36-71 months at 36 months after the full immunization.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- Experimental Vaccine, Control 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.
Experimental VaccineBiological
Also called Enterovirus Type 71 Vaccine（Vero Cell）, Inactivated
The EV71 vaccine was manufactured by Sinovac Biotech Co., Ltd and inactivated EV71 virus antigen was no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.
Control VaccineBiological
Also called Enterovirus Type 71 Vaccine, Inactivated（Human Diploid Cell）
The EV71 vaccine was manufactured by Institute of Medical Biology,Chinese Academy of Medical Sciences ,and inactivated EV71 virus antigen was no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group aged 6~23 months | Experimental | Up to 146 subjects aged 6~23 months and have received EV71 vaccine developed by Sinovac Biotech Co., Ltd will be collected blood samples at 36 months after full immunization and at the age of 72 months. Receives: Biological: Experimental Vaccine |
| Experimental Group aged 24~35 months | Experimental | Up to 128 subjects aged 24~35 months and have received EV71 vaccine developed by Sinovac Biotech Co., Ltd will be collected blood samples at 36 months after full immunization . Receives: Biological: Experimental Vaccine |
| Experimental Group aged 36~71 months | Experimental | 100 subjects aged 36~71 months and have received EV71 vaccine developed by Sinovac Biotech Co., Ltd will be collected blood samples at 36 months after full immunization . Receives: Biological: Experimental Vaccine |
| Control Group aged 36~71 months | Active comparator | 100 subjects aged 36~71 months and have received EV71 vaccine developed by Institute of Medical Biology,Chinese Academy of Medical Sciences will be collected blood samples at 36 months after full immunization . Receives: Biological: Control Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seroconversion rates (SCR) of EV71 neutralizing antibody of all enrolled subjects
The seroconversion rates (SCR) of EV71 neutralizing antibody of all subjects at 36 months after full immunization.
Measured: At 36 months after full immunization
The seroconversion rates (SCR) of the EV71 neutralizing antibody of subjects aged 6-23 months
The seroconversion rates (SCR) of the EV71 neutralizing antibody of subjects aged 6-23 months at the age of 72months.
Measured: At the age of 72 months
GMT of the EV71 neutralizing antibody of all enrolled subjects
GMT of the EV71 neutralizing antibody of all enrolled subjects at 36 months after full immunization.
Measured: At 36 months after full immunization
GMT of the EV71 neutralizing antibody of subjects aged 6-23 months
GMT of the EV71 neutralizing antibody of subjects aged 6-23 months at the age of 72months.
Measured: At the age of 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start30 Jul 2022 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
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
- 474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan Zheng, Master, Principal investigator, Yunnan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397587
- Sponsor's protocol ID
- PRO-EV71-3003-1
- Status last verified
- May 2022
- First submitted
- 25 May 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Observational Study to Evaluate the Immunity Persistence of an Inactivated Enterovirus 71 Vaccine (Vero Cell) in Subjects Aged 6 to 71 Months
- ClinicalTrials.gov ID
- NCT05397587
- Acronym / sponsor ID
- PRO-EV71-3003-1
- Conditions
- Hand, Foot and Mouth Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2022 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 31 May 2022 (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 is an open，observational and follow-up clinical trial based on the clinical trial of EV71 vaccine extended age group.The purpose of this study is to evaluate the immunity persistence of EV71 vaccine developed by Sinovac Biotech Co., Ltd in subjects aged 6 ~71 months after full immunization of two doses of vaccine.
Detailed description
This study is an open,observational and follow-up clinical trial of EV71 vaccine based on the clinical trial of EV71 vaccine extended age group.The main purpose of this study is to evaluate the immunity persistence of EV71 vaccine developed by Sinovac Biotech Co., Ltd in subjects aged 6~71 months after full immunization of two doses of vaccine.In this study, a total of 474 subjects from the EV71 vaccine extended age clinical trial who received two doses of experimental or control vaccine and were enrolled in the PPS set，including 274 subjects aged 6~35 months (the maximum number of subjects aged 6-23 months is 146, and the maximum number of subjects aged 24-35 months is 128),100 subjects aged 36~71 months and were enrolled in experimental group(EV71 vaccine developed by Sinovac Biotech Co., Ltd) and 100 subjects aged 36~71 months and were enrolled in control group(EV71 vaccine developed by Institute of Medical Biology,Chinese Academy of Medical Sciences) will be enrolled .Blood samples will be collected from subjects aged 6-23 months at 36 months after full immunization and at the age of 72 months.Blood samples will be collected from subjects aged 24 to 35 months at 36 months after full immunization.Blood samples will be collected from subjects aged 36-71 months at 36 months after the full immunization.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Group aged 6~23 months | Experimental | Biological: Experimental VaccineUp to 146 subjects aged 6~23 months and have received EV71 vaccine developed by Sinovac Biotech Co., Ltd will be collected blood samples at 36 months after full immunization and at the age of 72 months. |
| Experimental Group aged 24~35 months | Experimental | Biological: Experimental VaccineUp to 128 subjects aged 24~35 months and have received EV71 vaccine developed by Sinovac Biotech Co., Ltd will be collected blood samples at 36 months after full immunization . |
| Experimental Group aged 36~71 months | Experimental | Biological: Experimental Vaccine100 subjects aged 36~71 months and have received EV71 vaccine developed by Sinovac Biotech Co., Ltd will be collected blood samples at 36 months after full immunization . |
| Control Group aged 36~71 months | Active comparator | Biological: Control Vaccine100 subjects aged 36~71 months and have received EV71 vaccine developed by Institute of Medical Biology,Chinese Academy of Medical Sciences will be collected blood samples at 36 months after full immunization . |
Who may qualify
- Ages
- 6 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects in the EV71 vaccine extended age clinical trial who received two doses of experimental or control vaccine and were enrolled in the PPS set;
- Provide legal identification;
- Participants or guardians of the participants should be capable of understanding the written consent form and voluntarily participate in the clinical trial.
Key exclusion criteria (3 listed)
- Vaccination history of vaccines containing EV71 antigen components other than the EV71 vaccine expanded age group clinical trial;
- History of hand, foot and mouth disease caused EV71;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
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 |
|---|---|---|
| Experimental VaccineAlso: Enterovirus Type 71 Vaccine（Vero Cell）, InactivatedThe EV71 vaccine was manufactured by Sinovac Biotech Co., Ltd and inactivated EV71 virus antigen was no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection. | Biological | Experimental Group aged 24~35 months, Experimental Group aged 36~71 months, Experimental Group aged 6~23 months |
| Control VaccineAlso: Enterovirus Type 71 Vaccine, Inactivated（Human Diploid Cell）The EV71 vaccine was manufactured by Institute of Medical Biology,Chinese Academy of Medical Sciences ,and inactivated EV71 virus antigen was no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection. | Biological | Control Group aged 36~71 months |
Primary outcome
The seroconversion rates (SCR) of EV71 neutralizing antibody of all enrolled subjects
Time frame: At 36 months after full immunization
The seroconversion rates (SCR) of EV71 neutralizing antibody of all subjects at 36 months after full immunization.
The seroconversion rates (SCR) of the EV71 neutralizing antibody of subjects aged 6-23 months
Time frame: At the age of 72 months
The seroconversion rates (SCR) of the EV71 neutralizing antibody of subjects aged 6-23 months at the age of 72months.
GMT of the EV71 neutralizing antibody of all enrolled subjects
Time frame: At 36 months after full immunization
GMT of the EV71 neutralizing antibody of all enrolled subjects at 36 months after full immunization.
GMT of the EV71 neutralizing antibody of subjects aged 6-23 months
Time frame: At the age of 72 months
GMT of the EV71 neutralizing antibody of subjects aged 6-23 months at the age of 72months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
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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.
Yan Zheng, Master principal investigator
Yunnan Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental Vaccine in people with Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd at 1 site 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Zheng, Master (18987115640, yaqueer_zy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The seroconversion rates (SCR) of EV71 neutralizing antibody of all enrolled subjects (time frame: At 36 months after full immunization). The study lists 4 primary outcomes in all. 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 10 Jun 2022.