Hand, Foot and Mouth DiseasePhase 1/2NCT06063057
Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial
A Phase 1/2 study testing low dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated, medium dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated and high dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated in people with Hand, Foot and Mouth Disease and Herpangina, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
The Phase I clinical trial is divided into two parts. The first part uses an open-label design, while the second part uses a randomized, double-blind, and controlled design. The goal of this clinical trial is to evaluate the tolerability and safety of a bivalent (EV71/CA16, Enterovirus 71/Coxsackievirus A16)… Read more about this study
- Who is it for?
- Ages 6 months to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand, Foot and Mouth Disease, Herpangina
- What is being tested?
- low dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated, medium dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated and high dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 744 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2023to 10 Mar 2026
- Phase
- Phase 1/2
- 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 months to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy participants aged 18-59 years, 6-12 years, and 6-71 months.
- Participants and/or their guardians can understand and voluntarily sign the informed consent form (participants aged 8-12 years require dual signatures from both participants and their guardians).
- Willing and able to comply with all visit schedules, sample collection, vaccine administration, and other trial procedures.
- Provide legal identification of the participants and/or their guardians.
Who cannot join
- History of hand, foot, and mouth disease or EV71 vaccination.
- Known severe allergy to the vaccine or vaccine components, such as urticaria, respiratory distress, and angioedema.
- Congenital abnormalities or developmental disorders, genetic defects (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition, etc.
- Based on medical history and physical examination, the presence of severe chronic diseases, severe cardiovascular diseases, uncontrolled hypertension or diabetes, liver or kidney diseases, etc.
- Based on medical history and physical examination, the presence of autoimmune diseases, immunodeficiency diseases, and/or blood diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, thyroidectomy, autoimmune thyroid disease, any form of malignancy, asplenia, functional asplenia).
- Based on medical history and physical examination, abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or obvious bruising or bleeding disorders.
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- Based on medical history and physical examination, the presence of severe neurological diseases (epilepsy, convulsions, or seizures), mental illness, or corresponding family history.
- Long-term use (more than 14 days) of corticosteroids or other immunosuppressive agents (excluding corticosteroid sprays for allergic rhinitis and surface corticosteroid treatment for acute non-complicated dermatitis) or cytotoxic therapy or planning to receive such treatment during the trial.
- History of long-term alcohol abuse or drug abuse.
- Females who are breastfeeding, pregnant, or planning to become pregnant within 90 days, or females with positive pregnancy test results. Note: male participants whose spouse plans to become pregnant within 90 days are also included.
- Received immunoglobulin and/or other blood products in the past 3 months or planning to receive such treatment during the trial.
- Received other investigational drugs or vaccines within the past 30 days or planning to receive such drugs or vaccines during the trial.
- Vaccinated with attenuated live vaccines within the past 14 days or subunit or inactivated vaccines within the past 7 days.
- Suspected or confirmed fever within 72 hours before vaccination or axillary temperature >37.0℃ on the day of vaccination.
- Clinical laboratory testing shows laboratory abnormalities beyond the reference range and with clinical significance (applicable only to Phase I clinical trials for adults/6-12-year-old children/24-71-month-old children):
- Complete blood count: white blood cell count, hemoglobin, platelet count.B. Blood biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose (Glu).C. Urine routine: urine protein (PRO).
- Any acute illness (with or without fever) or exacerbation of chronic illness within the past 7 days.
- According to the investigator's judgment, there are any other factors that make the participant unsuitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Dayao County Center for Disease Control and Prevention
Chuxiong, Yunnan
About this study
Official title: Inactivated Bivalent Enterovirus Vaccine Phase I/II Clinical Trial: Open-Label Observation in Healthy Adults and Children, and Randomized, Double-Blind, Controlled Clinical Trial in Children
The Phase I clinical trial is divided into two parts. The first part uses an open-label design, while the second part uses a randomized, double-blind, and controlled design. The goal of this clinical trial is to evaluate the tolerability and safety of a bivalent (EV71/CA16, Enterovirus 71/Coxsackievirus A16) inactivated enterovirus vaccine (Vero cell) developed by Sinovac. The vaccine will be administered to healthy adults, children aged 6 to 12 years, and children aged 6 to 71 months.
The Phase II clinical trial will also use a randomized, double-blind, and controlled design to evaluate the safety and immunogenicity of the same bivalent inactivated enterovirus vaccine (Vero cell) developed by Sinovac. This trial will involve healthy children aged 6 to 71 months.
Read the detailed description
For phase I clinical trial:
The first part of the trial plans to recruit thirty-six healthy adults aged 18-59 years and thirty-six children aged 6-12 years, with twelve participants in each of the low-dose (EV71 480 U-CA16 600 SU/0.5 ml), medium-dose (EV71 960 U-CA16 600 SU/0.5 ml), and high-dose (EV71 1920U-CA16 1200SU/0.5ml) experimental groups. The participants will receive two doses of the experimental vaccine according to a 0-1-month schedule, with adults vaccinated before children.
The second part of the trial plans to recruit seventy-two healthy children aged 6-71 months, with each dose group having twelve participants in the 6-23 months and 24-71 months age groups. The participants will receive two doses of the experimental vaccine according to a 0-1-month schedule, with each dose group being randomized, double-blind, and positive-controlled. The vaccine will be compared to a control (EV71 vaccine) at each dose level.
The dose escalation principle within each age group is from low to high doses: After completing the first dose of the lower dose stage, a safety observation period of 0-7 days will be conducted to confirm safety based on adverse event occurrence and blood routine, blood biochemistry, and urine routine tests (if any) before proceeding to the higher dose stage. The sequential enrollment principle between different age groups is from adults and children aged 6-12 years to children aged 6-71 months. After the first dose of each dose group is administered to adults, children aged 6-12 years in the same dose group can be enrolled only after a safety observation period of 0-7 days confirms safety. After completing the second dose of the medium-dose group in adults, vaccination of children aged 6-71 months can begin.
Participants in the adult and children aged 6-12 years groups will have approximately 5.5 mL of blood (2.0 mL anticoagulated blood and 3.5 mL non-anticoagulated blood) and about 2-10 mL of urine samples collected before and on day three after each dose for blood routine, blood biochemistry, and urine routine tests to evaluate vaccine safety. Only participants aged 24-71 months in the second stage of the trial will undergo these tests before the first dose. Whether participants aged 24-71 months to conduct tests on days 3 (Visit2), 30 (Visit5), and 33 (Visit6) will depend on the relevant test results in the children aged 6-12 years group. If 10% of participants in each dose stage of the children aged 6-12 years group have abnormal test results related to the vaccine that is clinically significant after the first dose, blood and urine samples will be collected from corresponding dose stage participants aged 24-71 months on days 3 (Visit2), 30 (Visit5), and 33 (Visit6).
For phase II clinical trial:
A total of six hundred children aged 6-71 months will be recruited, including 360 children aged 6-23 months and 240 children aged 24-71 months. The participants will be randomly allocated to the low-dose (EV71 480U-CA16 600SU/0.5ml), medium-dose (EV71 960U-CA16 600SU/0.5ml), high-dose (EV71 1920U-CA16 1200SU/0.5ml) experimental groups and control group (EV71 vaccine) in a 1:1:1:1 ratio.
Participants will be given two doses of either the experimental or control vaccine, administered one month apart.
During phase II of the trial, all participants will undergo blood collection on three different days: day zero, day sixty, and day 210 after vaccination. The collection will involve approximately 3.0 mL of venous blood to be separated into serum for EV71 and CA16 neutralizing antibodies assays. These assays will help evaluate the immunogenicity and immune persistence of the vaccine.
All participants in phases I/II will be observed for immediate reactions within 30 minutes after each dose, and adverse events (AEs) will be collected for the first seven days after each dose and non-solicited AEs for the first 30 days after each dose. Serious adverse events (SAEs) will be monitored from the start of vaccination until six months after completion of the vaccination course. In phase I, pregnancy events within three months (120 days) after vaccination will be collected based on self-report.
Once safety data for all participants has been obtained for 30 days after completing the vaccination course in phase I, the investigators will seek ethics approval. If the safety results are deemed satisfactory and approved by the ethics committee, the investigators will move forward to phase II clinical trial.
- Conditions
- Hand, Foot and Mouth Disease, Herpangina
- Being tested
- low dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated, medium dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated, high dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated, Enterovirus type EV71 vaccine (Vero cell), Inactivated
- Keywords
- Inactivated enterovirus vaccine, Bivalent enterovirus vaccine
- Medical subject headings
- Hand, Foot and Mouth Disease, Herpangina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose Bivalent Enterovirus Vaccine (Vero Cell), InactivatedBiological
Bivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 480 U-CA16 600 SU/0.5 ml
medium dose Bivalent Enterovirus Vaccine (Vero Cell), InactivatedBiological
Bivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 960 U-CA16 600 SU/0.5 ml
high dose Bivalent Enterovirus Vaccine (Vero Cell), InactivatedBiological
Bivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 1920U-CA16 1200SU/0.5ml
Enterovirus type EV71 vaccine (Vero cell), InactivatedBiological
Enterovirus type EV71 vaccine (Vero cell), Inactivated (Sinovac)
| Study group | Role | What they receive |
|---|---|---|
| low-dose experimental group | Experimental | phase Ⅰ: 18~59 years old,6~12 years old,6~71 months old; phase Ⅱ：6~71 months old Receives: Biological: low dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated |
| medium-dose experimental group | Experimental | phase Ⅰ: 18~59 years old,6~12 years old,6~71 months old; phase Ⅱ：6~71 months old Receives: Biological: medium dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated |
| high-dose experimental group | Experimental | phase Ⅰ: 18~59 years old,6~12 years old,6~71 months old; phase Ⅱ：6~71 months old Receives: Biological: high dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated |
| Active control group | Active comparator | phase Ⅰ: 6~71 months old; phase Ⅱ：6~71 months old Receives: Biological: Enterovirus type EV71 vaccine (Vero cell), Inactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ⅰ: Based on adverse events, evaluate the safety of the trial vaccine among participants in different age groups
the incidence rates of adverse reactions from the start of vaccination to 30 days after the end of the entire vaccination course
Measured: 30 days
Phase Ⅱ: Evaluate the immunogenicity of the trial vaccine in the target population.
The seroconversion rate of EV71 and CA16 neutralizing antibodies in children aged 6-71 months 30 days after the end of the entire vaccination course.
Measured: 30 days
Secondary outcomes (12)
Phase Ⅰ: Based on adverse events, evaluate the safety of the trial vaccine among participants in different age groups.
- The incidence rate of adverse reactions from 0-7 days after each dose.
Measured: 7 days
Phase Ⅰ: Based on adverse events, evaluate the safety of the trial vaccine among participants in different age groups.
- The incidence rate of serious adverse events from the start of vaccination to 6 months after the end of the entire vaccination course.
Measured: 6 months
Phase Ⅰ: Based on laboratory abnormalities, evaluate the safety of the trial vaccine among participants in different age groups.
-The incidence rate of clinically significant abnormal blood biochemistry, blood routine, and urine routine indexes within 3 days after each dose.
Measured: 3 days
Phase Ⅱ: Evaluate other immunogenicity indicators of the trial vaccine.
-The seropositive rates of EV71 and CA16 neutralizing antibodies 30 days after the end of the entire vaccination course.
Measured: 30 days
Phase Ⅱ: Evaluate other immunogenicity indicators of the trial vaccine.
-The GMTs (Geometric Mean Titers) of EV71 and CA16 neutralizing antibodies 30 days after the end of the entire vaccination course.
Measured: 30 days
Phase Ⅱ: Evaluate other immunogenicity indicators of the trial vaccine.
-The GMFRs (Geometric Mean Fold Rise) of EV71 and CA16 neutralizing antibodies 30 days after the end of the entire vaccination course.
Measured: 30 days
Phase Ⅱ: Based on adverse events, evaluate the safety of the trial vaccine.
-The incidence rate of adverse reactions from the start of vaccination to 30 days after the end of the entire vaccination course.
Measured: 30 days
Phase Ⅱ: Based on adverse events, evaluate the safety of the trial vaccine.
-The incidence rate of adverse reactions from 0-7 days after each dose.
Measured: 7 days
Phase Ⅱ: Based on adverse events, evaluate the safety of the trial vaccine.
-The incidence rate of SAEs from the start of vaccination to 6 months after the end of the entire vaccination course.
Measured: 6 months
Phase Ⅱ: Evaluate the immune persistence of the trial vaccine.
-The seropositive rates of neutralizing antibodies against EV71 and CA16 6 months after the vaccination course.
Measured: 6 months
Phase Ⅱ: Evaluate the immune persistence of the trial vaccine.
-The seropositive rates of EV71, and CA16 neutralizing antibodies 6 months after the end of the entire vaccination course.
Measured: 6 months
Phase Ⅱ: Evaluate the immune persistence of the trial vaccine.
-The GMTs of EV71, and CA16 neutralizing antibodies 6 months after the end of the entire vaccination course.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start20 Sep 2023
- Primary completion19 Dec 2025
- Study completion10 Mar 2026
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 744 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zheng Yan, Principal investigator, Yunnan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063057
- Sponsor's protocol ID
- PRO-EV71/CA16-1001
- Status last verified
- Jan 2026
- First submitted
- 15 Sep 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inactivated Bivalent Enterovirus Vaccine Phase I/II Clinical Trial: Open-Label Observation in Healthy Adults and Children, and Randomized, Double-Blind, Controlled Clinical Trial in Children
- ClinicalTrials.gov ID
- NCT06063057
- Acronym / sponsor ID
- PRO-EV71/CA16-1001
- Conditions
- Hand, Foot and Mouth Disease, Herpangina
- Keywords
- Inactivated enterovirus vaccine, Bivalent enterovirus vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 2 Oct 2023 (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.
The Phase I clinical trial is divided into two parts. The first part uses an open-label design, while the second part uses a randomized, double-blind, and controlled design. The goal of this clinical trial is to evaluate the tolerability and safety of a bivalent (EV71/CA16, Enterovirus 71/Coxsackievirus A16) inactivated enterovirus vaccine (Vero cell) developed by Sinovac. The vaccine will be administered to healthy adults, children aged 6 to 12 years, and children aged 6 to 71 months.
The Phase II clinical trial will also use a randomized, double-blind, and controlled design to evaluate the safety and immunogenicity of the same bivalent inactivated enterovirus vaccine (Vero cell) developed by Sinovac. This trial will involve healthy children aged 6 to 71 months.
Detailed description
For phase I clinical trial:
The first part of the trial plans to recruit thirty-six healthy adults aged 18-59 years and thirty-six children aged 6-12 years, with twelve participants in each of the low-dose (EV71 480 U-CA16 600 SU/0.5 ml), medium-dose (EV71 960 U-CA16 600 SU/0.5 ml), and high-dose (EV71 1920U-CA16 1200SU/0.5ml) experimental groups. The participants will receive two doses of the experimental vaccine according to a 0-1-month schedule, with adults vaccinated before children.
The second part of the trial plans to recruit seventy-two healthy children aged 6-71 months, with each dose group having twelve participants in the 6-23 months and 24-71 months age groups. The participants will receive two doses of the experimental vaccine according to a 0-1-month schedule, with each dose group being randomized, double-blind, and positive-controlled. The vaccine will be compared to a control (EV71 vaccine) at each dose level.
The dose escalation principle within each age group is from low to high doses: After completing the first dose of the lower dose stage, a safety observation period of 0-7 days will be conducted to confirm safety based on adverse event occurrence and blood routine, blood biochemistry, and urine routine tests (if any) before proceeding to the higher dose stage. The sequential enrollment principle between different age groups is from adults and children aged 6-12 years to children aged 6-71 months. After the first dose of each dose group is administered to adults, children aged 6-12 years in the same dose group can be enrolled only after a safety observation period of 0-7 days confirms safety. After completing the second dose of the medium-dose group in adults, vaccination of children aged 6-71 months can begin.
Participants in the adult and children aged 6-12 years groups will have approximately 5.5 mL of blood (2.0 mL anticoagulated blood and 3.5 mL non-anticoagulated blood) and about 2-10 mL of urine samples collected before and on day three after each dose for blood routine, blood biochemistry, and urine routine tests to evaluate vaccine safety. Only participants aged 24-71 months in the second stage of the trial will undergo these tests before the first dose. Whether participants aged 24-71 months to conduct tests on days 3 (Visit2), 30 (Visit5), and 33 (Visit6) will depend on the relevant test results in the children aged 6-12 years group. If 10% of participants in each dose stage of the children aged 6-12 years group have abnormal test results related to the vaccine that is clinically significant after the first dose, blood and urine samples will be collected from corresponding dose stage participants aged 24-71 months on days 3 (Visit2), 30 (Visit5), and 33 (Visit6).
For phase II clinical trial:
A total of six hundred children aged 6-71 months will be recruited, including 360 children aged 6-23 months and 240 children aged 24-71 months. The participants will be randomly allocated to the low-dose (EV71 480U-CA16 600SU/0.5ml), medium-dose (EV71 960U-CA16 600SU/0.5ml), high-dose (EV71 1920U-CA16 1200SU/0.5ml) experimental groups and control group (EV71 vaccine) in a 1:1:1:1 ratio.
Participants will be given two doses of either the experimental or control vaccine, administered one month apart.
During phase II of the trial, all participants will undergo blood collection on three different days: day zero, day sixty, and day 210 after vaccination. The collection will involve approximately 3.0 mL of venous blood to be separated into serum for EV71 and CA16 neutralizing antibodies assays. These assays will help evaluate the immunogenicity and immune persistence of the vaccine.
All participants in phases I/II will be observed for immediate reactions within 30 minutes after each dose, and adverse events (AEs) will be collected for the first seven days after each dose and non-solicited AEs for the first 30 days after each dose. Serious adverse events (SAEs) will be monitored from the start of vaccination until six months after completion of the vaccination course. In phase I, pregnancy events within three months (120 days) after vaccination will be collected based on self-report.
Once safety data for all participants has been obtained for 30 days after completing the vaccination course in phase I, the investigators will seek ethics approval. If the safety results are deemed satisfactory and approved by the ethics committee, the investigators will move forward to phase II clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low-dose experimental group | Experimental | Biological: low dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivatedphase Ⅰ: 18~59 years old,6~12 years old,6~71 months old; phase Ⅱ：6~71 months old |
| medium-dose experimental group | Experimental | Biological: medium dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivatedphase Ⅰ: 18~59 years old,6~12 years old,6~71 months old; phase Ⅱ：6~71 months old |
| high-dose experimental group | Experimental | Biological: high dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivatedphase Ⅰ: 18~59 years old,6~12 years old,6~71 months old; phase Ⅱ：6~71 months old |
| Active control group | Active comparator | Biological: Enterovirus type EV71 vaccine (Vero cell), Inactivatedphase Ⅰ: 6~71 months old; phase Ⅱ：6~71 months old |
Who may qualify
- Ages
- 6 months to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Healthy participants aged 18-59 years, 6-12 years, and 6-71 months.
- Participants and/or their guardians can understand and voluntarily sign the informed consent form (participants aged 8-12 years require dual signatures from both participants and their guardians).
- Willing and able to comply with all visit schedules, sample collection, vaccine administration, and other trial procedures.
- Provide legal identification of the participants and/or their guardians.
Key exclusion criteria (18 listed)
- History of hand, foot, and mouth disease or EV71 vaccination.
- Known severe allergy to the vaccine or vaccine components, such as urticaria, respiratory distress, and angioedema.
- Congenital abnormalities or developmental disorders, genetic defects (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition, etc.
- Based on medical history and physical examination, the presence of severe chronic diseases, severe cardiovascular diseases, uncontrolled hypertension or diabetes, liver or kidney diseases, etc.
- Based on medical history and physical examination, the presence of autoimmune diseases, immunodeficiency diseases, and/or blood diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, thyroidectomy, autoimmune thyroid disease, any form of malignancy, asplenia, functional asplenia).
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 |
|---|---|---|
| low dose Bivalent Enterovirus Vaccine (Vero Cell), InactivatedBivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 480 U-CA16 600 SU/0.5 ml | Biological | low-dose experimental group |
| medium dose Bivalent Enterovirus Vaccine (Vero Cell), InactivatedBivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 960 U-CA16 600 SU/0.5 ml | Biological | medium-dose experimental group |
| high dose Bivalent Enterovirus Vaccine (Vero Cell), InactivatedBivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 1920U-CA16 1200SU/0.5ml | Biological | high-dose experimental group |
| Enterovirus type EV71 vaccine (Vero cell), InactivatedEnterovirus type EV71 vaccine (Vero cell), Inactivated (Sinovac) | Biological | Active control group |
Primary outcome
Phase Ⅰ: Based on adverse events, evaluate the safety of the trial vaccine among participants in different age groups
Time frame: 30 days
the incidence rates of adverse reactions from the start of vaccination to 30 days after the end of the entire vaccination course
Phase Ⅱ: Evaluate the immunogenicity of the trial vaccine in the target population.
Time frame: 30 days
The seroconversion rate of EV71 and CA16 neutralizing antibodies in children aged 6-71 months 30 days after the end of the entire vaccination course.
12 secondary outcomes
Phase Ⅰ: Based on adverse events, evaluate the safety of the trial vaccine among participants in different age groups.
Time frame: 7 days
Phase Ⅰ: Based on adverse events, evaluate the safety of the trial vaccine among participants in different age groups.
Time frame: 6 months
Phase Ⅰ: Based on laboratory abnormalities, evaluate the safety of the trial vaccine among participants in different age groups.
Time frame: 3 days
Phase Ⅱ: Evaluate other immunogenicity indicators of the trial vaccine.
Time frame: 30 days
Phase Ⅱ: Evaluate other immunogenicity indicators of the trial vaccine.
Time frame: 30 days
Phase Ⅱ: Evaluate other immunogenicity indicators of the trial vaccine.
Time frame: 30 days
Phase Ⅱ: Based on adverse events, evaluate the safety of the trial vaccine.
Time frame: 30 days
Phase Ⅱ: Based on adverse events, evaluate the safety of the trial vaccine.
Time frame: 7 days
Phase Ⅱ: Based on adverse events, evaluate the safety of the trial vaccine.
Time frame: 6 months
Phase Ⅱ: Evaluate the immune persistence of the trial vaccine.
Time frame: 6 months
Phase Ⅱ: Evaluate the immune persistence of the trial vaccine.
Time frame: 6 months
Phase Ⅱ: Evaluate the immune persistence of the trial vaccine.
Time frame: 6 months
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 26 Jun 2026.
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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.
Zheng Yan 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 1/2 study testing low dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated, medium dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated and high dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated in people with Hand, Foot and Mouth Disease and Herpangina, 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 4 inclusion and 18 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 26 Jun 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Phase Ⅰ: Based on adverse events, evaluate the safety of the trial vaccine among participants in different age groups (time frame: 30 days). 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?
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 26 Jun 2026.