Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell)
A Multicenter, Randomized, Double-blind, Controlled Phase III Clinical Trial on the Efficacy, Safety, and Immunogenicity of the Bivalent Enterovirus Inactivated Vaccine (Vero Cell) in Children Aged 6 to 71 Months.
Sinovac Biotech Co., Ltd
8,000 participants
Dec 13, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Healthy children aged 6 to 71 months with no history of EV71 vaccination; or healthy children aged 24 to 71 months who have completed two doses of EV71 vaccine at least 6 months prior.
- Guardians who can understand and voluntarily sign the informed consent form.
- Willing and able to comply with all visit schedules, sample collections, vaccinations, and other research procedures.
- Provide proof of identity documents.
Exclusion Criteria16
- A known history of HFMD/HA.
- Uncontrolled chronic diseases or a history of severe illnesses, including but not limited to cardiovascular diseases, blood disorders, liver or kidney diseases, digestive system diseases, respiratory system diseases, malignant tumors, or a history of major functional organ transplantation.
- Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection).
- Abnormal coagulation function (such as coagulation factor deficiencies, and platelet abnormalities).
- Suffering from/having a history of severe neurological diseases (epilepsy, convulsions, or seizures \[excluding a history of febrile seizures\]) psychiatric disorders, or a family history of psychiatric disorders.
- Various acute diseases or exacerbations of chronic diseases within the last 3 days, or known or suspected active infections.
- Received a vaccine containing CA16 components.
- Received immunosuppressive or other immunomodulatory treatments for ≥14 days within the past 6 months (prednisone ≥2mg/kg/day, or its equivalent; local or inhaled corticosteroids excluded), cytotoxic therapy, or planning to receive such treatment during the trial.
- Received immunoglobulin or other blood products within the past 6 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.
- Received live attenuated vaccines or nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days.
- Known allergy to any component of the investigational vaccine (inactivated EV71 virus, inactivated CA16 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, injectable water).
- On the day of the planned vaccination with the trial vaccine, there is a fever, with axillary temperature > 37.0°C before vaccination;
- On the day of the planned vaccination with the trial vaccine, the physical examination is not qualified.
- Skin damage, inflammation, ulcers, rash, or scars at the target injection site that may interfere with vaccination or observation of local reactions.
- According to the investigator's judgment, participants have any other factors that make them unsuitable for participation in the clinical trial.
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Interventions
Two doses are administered with a one-month interval between each dose.
Two doses are administered with a one-month interval between each dose.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06734832