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

NCT06734832 | Recruiting Phase 3

• 1 other identifier: PRO-EV71CA16-3001
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hand, Foot, and Mouth Disease（HFMD)

Keywords

bivalent enterovirus inactivated vaccine; Hand, Foot, and Mouth Disease; EV71; CA16; PHASE Ⅲ; vaccine efficacy; immonogenicity; safety

Outcome Measures

Primary Outcomes (2)

• Evaluate the primary vaccine efficacy of the trial vaccine against HFMD caused by CA16 infection compared to the control vaccine.

  Evaluate the primary vaccine efficacy of the trial vaccine against HFMD caused by CA16 infection, diagnosed by RT-PCR, in children aged 6 to 71 months (with and without a history of EV71 vaccination) 14 days after full vaccination (based on data from at least 47 cases). The vaccine's efficacy will be evaluated by monitoring the annual incidence rate of HFMD attributable to CA16 infection, as confirmed by reverse transcription polymerase chain reaction (RT-PCR) nucleic acid testing, following complete full immunization for 14 days based on data from at least 47 cases until the end of one epidemic seasons.

  1 year

• Evaluate whether the neutralizing antibody levels against EV71 in the trial group are non-inferior to those in the control group after two doses of vaccination.

  Evaluate the seroconversion rate and geometric mean titer (GMT) of EV71 neutralizing antibodies in participants aged 6-71 months without a history of EV71 vaccination and negative for EV71 antibodies before immunization, 30 days after full vaccination.

  60 days

Secondary Outcomes (23)

• Evaluate the safety of the trial vaccine.

  6 monthes

• Evaluate the long-term vaccine efficacy of the trial vaccine compared to the control vaccine against HFMD caused by CA16 infection

  2 years

• Evaluate the long-term vaccine efficacy of the trial vaccine compared to the control vaccine against Herpangina(HA) caused by CA16 infection

  2 years

• Evaluate the seroconversion rate of the neutralizing antibodies against CA16 and EV71 in populations without a history of EV71 vaccination.

  60 days

• Evaluate the seropositivity rate of neutralizing antibodies against CA16 and EV71 in populations without a history of EV71 vaccination.

  60 days

Study Arms (2)

trial group

EXPERIMENTAL

Bivalent enterovirus inactivated vaccine (Vero cell)

Biological: bivalent enterovirus vaccine (Vero cell), inactivated

control group

ACTIVE COMPARATOR

Enterovirus Type 71 Vaccine (Vero Cell), Inactivated

Biological: Enterovirus Type 71 Vaccine (Vero Cell), Inactivated

Interventions

bivalent enterovirus vaccine (Vero cell), inactivated BIOLOGICAL

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

trial group

Enterovirus Type 71 Vaccine (Vero Cell), Inactivated BIOLOGICAL

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

control group

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 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.

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, 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.

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (4)

Anhui Provincial Center for Disease Control and Prevention

Hefei, Anhui, China

RECRUITING

Fujian Provincial Center for Disease Control and Prevention

Fujian, China

RECRUITING

Guangdong Provincial Center for Disease Control and Prevention

Guangdong, 650000, China

RECRUITING

Hubei Provincial Center for Disease Control and Prevention

Hubei, China

RECRUITING

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Liu Xiaoqiang, Dr.

  Yunnan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Xiaoqiang, Dr.

CONTACT

98-15911568282; lxq7611@126.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: December 4, 2024
• First Posted: December 16, 2024
• Study Start: December 13, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

CN (4)