Actively Recruiting
Study of the Bivalent Enterovirus Inactivated Vaccine (Vero Cell) Compared to the EV71 Vaccine in Children Aged 6 to 71 Months Evaluating Efficacy, Safety, and Immune Response
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
Researchers are evaluating the efficacy, safety, and immune response of a bivalent enterovirus-inactivated vaccine (Vero cell) in healthy children aged 6 to 71 months. This Phase III, multicenter, randomized, double-blind, controlled trial compares this investigational vaccine to an EV71-inactivated vaccine (Vero cell) to prevent Hand, Foot, and Mouth Disease (HFMD) caused by CA16 infection and Herpangina (HA). The study aims to determine the primary vaccine efficacy against HFMD from CA16 and whether the neutralizing antibody levels against EV71 in the trial group are not inferior to those in the control group after two vaccine doses. Participants are randomly assigned in equal numbers to receive either two doses of the bivalent enterovirus vaccine or the control EV71 vaccine, with a one-month interval between doses. After the first dose, participants enter a monitoring period that lasts through two consecutive epidemic seasons. Subgroups of participants are selected for detailed safety monitoring, immune response testing, and analysis of injection site effects. Blood samples are collected at multiple time points to measure antibody levels and immune cell activity. Adverse events are closely tracked from vaccination through several months afterward. During the study, researchers actively follow participants for signs of enterovirus infection. If symptoms appear, throat or rectal swabs are collected for laboratory testing to confirm infection types. Safety is monitored by recording all adverse events shortly after vaccination and serious adverse events for six months after the second dose. The trial includes a detailed schedule of visits, sample collections, and vaccinations to evaluate vaccine protection, immune response, and safety over a one-year period. Genetic analysis of virus samples helps further understand infection subtypes.
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
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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.
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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