Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial
1 other identifier
interventional
744
1 country
1
Brief 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) 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2023
CompletedStudy Start
First participant enrolled
September 20, 2023
CompletedFirst Posted
Study publicly available on registry
October 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2026
CompletedJanuary 16, 2026
January 1, 2026
2.2 years
September 15, 2023
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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.
30 days
Secondary Outcomes (12)
Phase Ⅰ: Based on adverse events, evaluate the safety of the trial vaccine among participants in different age groups.
7 days
Phase Ⅰ: Based on adverse events, evaluate the safety of the trial vaccine among participants in different age groups.
6 months
Phase Ⅰ: Based on laboratory abnormalities, evaluate the safety of the trial vaccine among participants in different age groups.
3 days
Phase Ⅱ: Evaluate other immunogenicity indicators of the trial vaccine.
30 days
Phase Ⅱ: Evaluate other immunogenicity indicators of the trial vaccine.
30 days
- +7 more secondary outcomes
Study Arms (4)
low-dose experimental group
EXPERIMENTALphase Ⅰ: 18\~59 years old,6\~12 years old,6\~71 months old; phase Ⅱ：6\~71 months old
medium-dose experimental group
EXPERIMENTALphase Ⅰ: 18\~59 years old,6\~12 years old,6\~71 months old; phase Ⅱ：6\~71 months old
high-dose experimental group
EXPERIMENTALphase Ⅰ: 18\~59 years old,6\~12 years old,6\~71 months old; phase Ⅱ：6\~71 months old
Active control group
ACTIVE COMPARATORphase Ⅰ: 6\~71 months old; phase Ⅱ：6\~71 months old
Interventions
Bivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 1920U-CA16 1200SU/0.5ml
Enterovirus type EV71 vaccine (Vero cell), Inactivated (Sinovac)
Bivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 960 U-CA16 600 SU/0.5 ml
Bivalent Enterovirus Vaccine (Vero Cell), Inactivated antigen content: EV71 480 U-CA16 600 SU/0.5 ml
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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):
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dayao County Center for Disease Control and Prevention
Chuxiong, Yunnan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zheng Yan
Yunnan Provincial Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2023
First Posted
October 2, 2023
Study Start
September 20, 2023
Primary Completion
December 19, 2025
Study Completion
March 10, 2026
Last Updated
January 16, 2026
Record last verified: 2026-01