EV71 VaccinePhase 4NCT07026500
Clinical Trial for Batch Consistency of EV71 Vaccine
A Phase 4 study testing EV71 Vaccine in people with EV71 Vaccine, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
This trial is designed as a single-center, randomized, double-blind study. A total of 720 infants aged 6 to 35 months are selected (with 240 subjects in each age group: 6-11 months, 12-23 months, and 24-35 months). Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- EV71 Vaccine
- What is being tested?
- EV71 Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2019to 31 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
- Infants and young children aged 6 to 35 months.
- Able to provide legal identification.
- The guardian of the subject has the ability to understand and agrees to sign the informed consent form.
Who cannot join
- Previous vaccination with the EV71 vaccine.
- History of hand, foot, and mouth disease.
- History of allergies, asthma, including allergies to vaccines or vaccine components, and severe adverse reactions to vaccines, such as urticaria, difficulty breathing, angioedema, or abdominal pain.
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Autoimmune diseases or immune deficiencies/immunosuppression.
- Severe neurological disorders (epilepsy, convulsions, or seizures) or mental illness.
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- History of thyroidectomy, asplenia, functional asplenia, or any condition leading to asplenia or splenectomy.
- Blood coagulation abnormalities diagnosed by a physician (such as clotting factor deficiencies, coagulopathies, platelet abnormalities) or evident bruising or bleeding disorders.
- Treatment with immunosuppressants, cytotoxic therapy, or inhaled corticosteroids within 6 months prior to enrollment (excluding corticosteroid nasal spray therapy for allergic rhinitis, or topical corticosteroid treatment for acute non-complicated dermatitis).
- Receipt of blood products within 3 months prior to vaccination with the trial vaccine.
- Receipt of other investigational vaccines within 30 days prior to vaccination with the trial vaccine.
- Receipt of live attenuated vaccines within 14 days prior to vaccination with the trial vaccine.
- Receipt of subunit or inactivated vaccines within 7 days prior to vaccination with the trial vaccine.
- Any acute illness or acute exacerbation of chronic illness within the past 7 days.
- Fever before receiving the investigational vaccine, with an axillary temperature > 37.0°C.
- Any other factors that, in the investigator's judgment, make the subject unsuitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Batch Consistency of the EV71 Vaccine in Infants Aged 6 to 35 Months After Vaccination According to a Two-dose Immunization Schedule
This trial is designed as a single-center, randomized, double-blind study. A total of 720 infants aged 6 to 35 months are selected (with 240 subjects in each age group: 6-11 months, 12-23 months, and 24-35 months). Subjects from different age groups are randomly allocated to three batch groups in a 1:1:1 ratio, and receive two doses of the EV71 vaccine from the commercial production batch on days 0 and 30. After each vaccination dose, subjects will be observed for immediate reactions for 30 minutes and for solicited adverse events for the next 7 days, as well as for unsolicited adverse events over the 30 days following vaccination. All subjects will have blood samples collected on day 0 (pre-immunization) and day 60 for serum antibody testing. Additionally, 270 subjects will be selected, for additional blood sampling at various time points: 7 days, 14 days, and 30 days after the first dose, and 7 days and 14 days after the second dose, to assess the EV71 antibody levels at different timepoints following various doses of vaccination.
- Conditions
- EV71 Vaccine
- Being tested
- EV71 Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV71 VaccineBiological
EV71 vaccine of commercial production batch
| Study group | Role | What they receive |
|---|---|---|
| Batch group 1 | Experimental | EV71 vaccine first commercial production batch Receives: Biological: EV71 Vaccine |
| Batch group 2 | Experimental | EV71 vaccine second commercial production batch Receives: Biological: EV71 Vaccine |
| Batch group 3 | Experimental | EV71 vaccine third commercial production batch Receives: Biological: EV71 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The GMT of EV71 neutralizing antibodies 30 days after complete immunization with the EV71 vaccine
Measured: 30 days after second dose
Secondary outcomes (5)
Seroconversion rates, seropositive rates, and GMT of antibodies at 7 days, 14 days, and 30 days after the first dose of the EV71 vaccine
Measured: 7,14 and 30 days after the first dose
Seroconversion rates, seropositive rates, and GMT of antibodies at 7 days and 14 days after the second dose of the EV71 vaccine, as well as the seroconversion rate and seropositive rate at 30 days post-vaccination
Measured: 7,14 and 30 days after the second dose
The incidence of adverse reactions within 30 days after each dose of the EV71 vaccine
Measured: 30 days after each dose
The incidence of solicited adverse events within 0-7 days after each dose of the EV71 vaccine
Measured: 7 days after each dose
The incidence of serious adverse events during the safety observation period
Measured: 30 days after the second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start19 Sep 2019
- Primary completion30 Apr 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EV71 VaccineStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026500
- Sponsor's protocol ID
- PRO-EV71-4009
- Other IDs
- CTR20191800
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Batch Consistency of the EV71 Vaccine in Infants Aged 6 to 35 Months After Vaccination According to a Two-dose Immunization Schedule
- ClinicalTrials.gov ID
- NCT07026500
- Acronym / sponsor ID
- PRO-EV71-4009
- Conditions
- EV71 Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 18 Jun 2025 (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 trial is designed as a single-center, randomized, double-blind study. A total of 720 infants aged 6 to 35 months are selected (with 240 subjects in each age group: 6-11 months, 12-23 months, and 24-35 months). Subjects from different age groups are randomly allocated to three batch groups in a 1:1:1 ratio, and receive two doses of the EV71 vaccine from the commercial production batch on days 0 and 30. After each vaccination dose, subjects will be observed for immediate reactions for 30 minutes and for solicited adverse events for the next 7 days, as well as for unsolicited adverse events over the 30 days following vaccination. All subjects will have blood samples collected on day 0 (pre-immunization) and day 60 for serum antibody testing. Additionally, 270 subjects will be selected, for additional blood sampling at various time points: 7 days, 14 days, and 30 days after the first dose, and 7 days and 14 days after the second dose, to assess the EV71 antibody levels at different timepoints following various doses of vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Batch group 1 | Experimental | Biological: EV71 VaccineEV71 vaccine first commercial production batch |
| Batch group 2 | Experimental | Biological: EV71 VaccineEV71 vaccine second commercial production batch |
| Batch group 3 | Experimental | Biological: EV71 VaccineEV71 vaccine third commercial production batch |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants and young children aged 6 to 35 months.
- Able to provide legal identification.
- The guardian of the subject has the ability to understand and agrees to sign the informed consent form.
Key exclusion criteria (16 listed)
- Previous vaccination with the EV71 vaccine.
- History of hand, foot, and mouth disease.
- History of allergies, asthma, including allergies to vaccines or vaccine components, and severe adverse reactions to vaccines, such as urticaria, difficulty breathing, angioedema, or abdominal pain.
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Autoimmune diseases or immune deficiencies/immunosuppression.
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 commercial production batch | Biological | Batch group 1, Batch group 2, Batch group 3 |
Primary outcome
The GMT of EV71 neutralizing antibodies 30 days after complete immunization with the EV71 vaccine
Time frame: 30 days after second dose
5 secondary outcomes
Seroconversion rates, seropositive rates, and GMT of antibodies at 7 days, 14 days, and 30 days after the first dose of the EV71 vaccine
Time frame: 7,14 and 30 days after the first dose
Seroconversion rates, seropositive rates, and GMT of antibodies at 7 days and 14 days after the second dose of the EV71 vaccine, as well as the seroconversion rate and seropositive rate at 30 days post-vaccination
Time frame: 7,14 and 30 days after the second dose
The incidence of adverse reactions within 30 days after each dose of the EV71 vaccine
Time frame: 30 days after each dose
The incidence of solicited adverse events within 0-7 days after each dose of the EV71 vaccine
Time frame: 7 days after each dose
The incidence of serious adverse events during the safety observation period
Time frame: 30 days after the second 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 18 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for EV71 Vaccine
Active, not recruitingPhase 3
A Study to Evaluate the Immunogenicity and Safety of an EV71 Vaccine (Envacgen®) in Children Aged 6 to <10 Years Compared to Children Aged 2 to <6 Years
Enterovirus 71 Inactivated Vaccine
Not yet recruiting
Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children
Hand, Foot, and Mouth Disease (HFMD), Enterovirus 71 Infection
Enrolling by invitationObservational study
Study on the Persistence of Immunity Following EV71 Vaccination
Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD)
RecruitingPhase 3
Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 EV71 Vaccine in people with EV71 Vaccine, 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 16 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 18 Jun 2025. 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 GMT of EV71 neutralizing antibodies 30 days after complete immunization with the EV71 vaccine (time frame: 30 days after second dose). 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 18 Jun 2025.