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Clinical Trials in China / NCT06734832
Recruiting Phase 3

Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell)

NCT06734832 · tracked via the Priya Life Science China tracker
Sponsor
Sinovac Biotech Co., Ltd
Phase
Phase 3
Started
2024-12-13
Last updated
2025-01-01

Condition(s) studied

Hand, Foot, and Mouth Disease(HFMD)

Investigational drug(s) / intervention(s)

bivalent enterovirus vaccine (Vero cell), inactivatedEnterovirus Type 71 Vaccine (Vero Cell), Inactivated

bivalent enterovirus vaccine (Vero cell), inactivated: Two doses are administered with a one-month interval between each dose.

Enterovirus Type 71 Vaccine (Vero Cell), Inactivated: Two doses are administered with a one-month interval between each dose.

Study 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

Sex
ALL
Min age
6 Months
Max age
71 Months
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Anhui Provincial Center for Disease Control and Prevention Hefei Anhui Recruiting
Fujian Provincial Center for Disease Control and Prevention Fujian China Recruiting
Guangdong Provincial Center for Disease Control and Prevention Guangdong China Recruiting
Hubei Provincial Center for Disease Control and Prevention Hubei China Recruiting

More Sinovac Biotech Co., Ltd trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06734832 on ClinicalTrials.gov ↗ ← All trials in China