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Starting soon Phase 3

Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).

NCT07611513 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2026-05
Last updated
2026-05-28

Condition(s) studied

Hand, Foot, and Mouth Disease(HFMD)Herpangina

Investigational drug(s) / intervention(s)

Tetravalent Inactivated Enterovirus Vaccine (Vero Cell)Placebo

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

Placebo: Two doses are administered with a one-month interval between each dose.

Study summary

This multicenter, randomized, double-blind, placebo-controlled phase IIIa clinical trial aims to evaluate the protective efficacy , immunogenicity and safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) in Children aged 6 to 71 months.

Participants will be randomly assigned in a 1:1 ratio to the trial group and the placebo group, receiving two doses of experimental vaccine or placebo , with a one-month interval between the two doses.

Eligibility

Sex
ALL
Min age
6 Months
Max age
71 Months
Healthy volunteers
Accepted
Inclusion Criteria: 1. Healthy children aged 6 to 71 months. 2. Guardians who can understand and voluntarily sign the informed consent form 3. Willing and able to comply with all visit schedules, sample collection, vaccinations, and other trial procedures。 4. Provide legal identification for the participant and their guardian Exclusion Criteria: 1. A known history of HFMD/HA 2. 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. 3. Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection). 4. Abnormal coagulation function (such as coagulation factor deficiencies,and platelet abnormalities). 5. 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 6. Various acute diseases or exacerbations of chronic diseases within the last 3 days. 7. Having been vaccinated with a vaccine containing any of the components EV71, CA16, CA10, CA6. 8. Having received ≥14 days of immunosuppressive or other immunomodulatory treatment (prednisone ≥2mg/kg/day, or its equivalent; local or inhaled corticosteroids excluded) within the past 6 months, or cytotoxic treatment, or planning to receive such treatment during the trial. 9. Having received immunoglobulin or other blood products(excluding hepatitis B immunoglobulin) within the past 6 months, or planning to receive such treatment during the trial. 10. Having received other investigational drugs or vaccines within the past 30 days, or planning to receive such drugs or vaccines during the trial. 11. Having received live attenuated vaccines or nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days. 12. Known allergy to any component of the investigational vaccine (inactivated EV71 virus, inactivated CA16 virus, , inactivated CA10 virus,, inactivated CA6 virus,aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, injectable water). 13. On the day of planned vaccination with the investigational vaccine, having an axillary temperature ≥37.3°C before vaccination, or other vital sign measurements outside the normal range,or the physical examination is not qualified. 14. 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)

  • Evaluate the protective efficacy of the investigational vaccine against HFMD caused by any serotype of EV71, CA16, CA10 and CA6 infection compared to placebo. — From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)
    Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed primary HFMD caused by any serotype of EV71, CA16, CA10 and CA6 in children aged 6 to 71 months starting from Day 15 after full-course vaccination during the primary protective efficacy analysis stage.
  • Evaluate the protective efficacy of the investigational vaccine against HFMD caused by CA6 infection compared to placebo. — From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)From day 15 after the full-course vaccination to data cutoff date of primary analysis
    Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed primary HFMD caused by CA6 in children aged 6 to 71 months starting from Day 15 after full-course vaccination during the primary protective efficacy analysis stage.
  • Evaluate the protective efficacy of the investigational vaccine against HFMD caused by CA16 infection compared to placebo. — From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)
    Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed primary HFMD caused by CA16 in children aged 6 to 71 months starting from Day 15 after full-course immunization during the primary protective efficacy analysis stage.

Trial sites (5)

FacilityCityRegionStatus
Anhui Provincial Center for Disease Control and Prevention Hefei Anhui
Fujian Provincial Center for Disease Control and Prevention Fujian China
Henan Provincial Center for Disease Control and Prevention Henan China
Hubei Provincial Center for Disease Control and Prevention Hubei China
Sichuan Provincial Center for Disease Control and Prevention Sichuan 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 NCT07611513 on ClinicalTrials.gov ↗ ← All trials in China