Actively Recruiting
Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell)
Led by Sinovac Biotech Co., Ltd · Updated on 2025-01-01
8000
Participants Needed
4
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter, randomized, double-blind, controlled Phase III clinical trial aims to evaluate the efficacy, safety, and immunogenicity of the bivalent enterovirus-inactivated vaccine (Vero cell) in healthy children aged 6 to 71 months. The main questions it aims to answer are: * The primary vaccine efficacy of the investigational vaccine against Hand, Foot, and Mouth Disease（HFMD) caused by CA16 infection compared to the control vaccine. * The neutralizing antibody levels against EV71 in the trial group are non-inferior to those in the control group after two doses of vaccination. Researchers will compare the bivalent enterovirus-inactivated vaccine (Vero cell) to the EV71-inactivated vaccine (Vero cell) to prevent HFMD and Herpangina(HA). Participants will be randomly assigned to the trial group and the control group in a 1:1 ratio to receive two doses of the investigational vaccine or the control EV71 vaccine, with a one-month interval between doses.
CONDITIONS
Official Title
Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy children aged 6 to 71 months with no history of EV71 vaccination; or healthy children aged 24 to 71 months who completed two doses of EV71 vaccine at least 6 months prior
- Guardians who understand and voluntarily sign the informed consent form
- Willing and able to follow all visit schedules, sample collections, vaccinations, and research procedures
- Provide proof of identity documents
You will not qualify if you...
- Known history of Hand, Foot, and Mouth Disease or Herpangina
- Uncontrolled chronic diseases or severe illnesses including cardiovascular, blood, liver, kidney, digestive, respiratory diseases, malignant tumors, or major organ transplant history
- Autoimmune or immunodeficiency diseases such as lupus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, or HIV infection
- Abnormal blood clotting conditions
- Severe neurological diseases, psychiatric disorders, or family history of psychiatric disorders
- Acute illnesses or worsening chronic diseases within the last 3 days, or active infections
- Previous vaccination with CA16-containing vaccines
- Immunosuppressive or immunomodulatory treatments for 14 days or more within the past 6 months
- Immunoglobulin or blood product treatments within past 6 months
- Investigational drugs or vaccines within past 30 days
- Live attenuated or nucleic acid vaccines within past 14 days; subunit or inactivated vaccines within past 7 days
- Known allergy to any vaccine components
- Fever over 37.06C or unqualified physical exam on vaccination day
- Skin issues at injection site interfering with vaccination or observation
- Other factors judged by investigators as unsuitable for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Anhui Provincial Center for Disease Control and Prevention
Hefei, Anhui, China
Actively Recruiting
2
Fujian Provincial Center for Disease Control and Prevention
Fujian, China
Actively Recruiting
3
Guangdong Provincial Center for Disease Control and Prevention
Guangdong, China, 650000
Actively Recruiting
4
Hubei Provincial Center for Disease Control and Prevention
Hubei, China
Actively Recruiting
Research Team
L
Liu Xiaoqiang, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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