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

NCT07611513 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: PRO-QEV-3001
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Hand, Foot, and Mouth Disease(HFMD); Herpangina

Keywords

Hand, Foot, and Mouth Disease (HFMD); Herpangina; phase IIIa; immunogenicity; safety; protective efficacy

Outcome Measures

Primary Outcomes (3)

• Evaluate the protective efficacy of the investigational vaccine against HFMD caused by any serotype of EV71, CA16, CA10 and CA6 infection compared to placebo.

  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.

  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 against HFMD caused by CA6 infection compared to placebo.

  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.

  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 against HFMD caused by CA16 infection compared to placebo.

  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.

  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)

Secondary Outcomes (26)

• Evaluate the safety of the investigational vaccine

  From day 0 to day 30 after vaccination (The day of vaccination is defined as Day 0)

• Evaluate the safety of the investigational vaccine

  From day of vaccination to 6 months after vaccination

• Evaluate the seroconversion rate of neutralizing antibodies against EV71, CA16, CA10, CA6

  At day 30 after full-course vaccination

• Evaluate the seropositivity rate of neutralizing antibodies against EV71, CA16, CA10, CA6

  At day 30 after full-course vaccination

• Evaluate the GMT of neutralizing antibodies against EV71, CA16, CA10, CA6

  At day 30 after full-course vaccination

Other Outcomes (7)

• Evaluate the protective efficacy of the investigational vaccine compared to placebo against diseases caused by infections with other untyped enteroviruses excluding EV71, CA16, CA10 and CA6 .

  From day 15 after full-course vaccination to the end of case surveillance period (December 31, 2027)

• Evaluate the seroconversion rate of neutralizing antibodies against different subtype strains

  Day 30 after full-course vaccination

• Evaluate the seropositivity rate of neutralizing antibodies against different subtype strains

  Day 30 after full-course vaccination

Study Arms (2)

Tetravalent Inactivated Enterovirus Vaccine (Vero Cell)

EXPERIMENTAL

3000 participants aged 6-71 months will receive Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.

Biological: Tetravalent Inactivated Enterovirus Vaccine (Vero Cell)

placebo

PLACEBO COMPARATOR

3000 participants aged 6-71 months will receive placebo .Route of administration is intramuscular injection at anterolateral thigh for infants aged younger than 12 months, and at deltoid muscle of upper arm for children aged older than 12 months.

Biological: Placebo

Interventions

Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) BIOLOGICAL

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

Tetravalent Inactivated Enterovirus Vaccine (Vero Cell)

Placebo BIOLOGICAL

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

placebo

Eligibility Criteria

• Age: 6 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged 6 to 71 months.
• Guardians who can understand and voluntarily sign the informed consent form
• Willing and able to comply with all visit schedules, sample collection, vaccinations, and other trial procedures。
• Provide legal identification for the participant and their guardian

You may not qualify if:

• 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.
• Having been vaccinated with a vaccine containing any of the components EV71, CA16, CA10, CA6.
• 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.
• 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.
• Having received other investigational drugs or vaccines within the past 30 days, or planning to receive such drugs or vaccines during the trial.
• Having 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, , inactivated CA10 virus,, inactivated CA6 virus,aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, injectable water).
• 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.
• According to the investigator's judgment, participants have any other factors that make them unsuitable for participation in the clinical trial.

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (5)

Anhui Provincial Center for Disease Control and Prevention

Hefei, Anhui, China

Location

Fujian Provincial Center for Disease Control and Prevention

Fujian, China

Location

Henan Provincial Center for Disease Control and Prevention

Henan, China

Location

Hubei Provincial Center for Disease Control and Prevention

Hubei, China

Location

Sichuan Provincial Center for Disease Control and Prevention

Sichuan, China

Location

MeSH Terms

Conditions

Hand, Foot and Mouth Disease; Herpangina

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Echovirus Infections

Study Officials

• Yanxia Wang

  Henan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanxia Wang

CONTACT

13613816598; wangyanxia99@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

CN (5)