Active — Not RecruitingPhase 1/2

Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial

China744 participantsStarted 2023-09-20

Plain-language 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.

Who can participate

Age range6 Months – 59 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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, coagulati…

What they're measuring

Phase Ⅰ: Based on adverse events, evaluate the safety of the trial vaccine among participants in different age groups

Timeframe: 30 days

Phase Ⅱ: Evaluate the immunogenicity of the trial vaccine in the target population.

Timeframe: 30 days

Trial details

NCT IDNCT06063057

SponsorSinovac Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-19