Evaluating a new vaccine for Hand, Foot, and Mouth Disease in young children

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.

This study is testing a new vaccine to see if it can help protect young children from Hand, Foot, and Mouth Disease.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8000 (estimated)
• Ages: 6 Months to 71 Months
• Sex: All
• Sponsor: Sinovac Biotech Co., Ltd (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 4 sites (Hefei, Anhui and 3 other locations)
• Trial ID: NCT06734832 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial is designed to assess the efficacy, safety, and immunogenicity of a bivalent inactivated enterovirus vaccine in healthy children aged 6 to 71 months. The study will enroll 8000 participants, who will be randomly assigned to receive either the investigational vaccine or a control vaccine, with two doses administered one month apart. Researchers will monitor participants for cases of Hand, Foot, and Mouth Disease and Herpangina, collecting samples for testing to evaluate the vaccine's protective efficacy. The trial aims to determine if the new vaccine can effectively prevent infections caused by enteroviruses.

Who should consider this trial

Good fit: Ideal candidates are healthy children aged 6 to 71 months with no prior history of EV71 vaccination.

Not a fit: Patients with a known history of Hand, Foot, and Mouth Disease or severe chronic illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could significantly reduce the incidence of Hand, Foot, and Mouth Disease in young children.

How similar studies have performed: Other studies have shown promise with similar vaccine approaches, indicating potential for success in this trial.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 3 other locations

• 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, China (Recruiting)
• Hubei Provincial Center for Disease Control and Prevention — Hubei, China (Recruiting)

Study contacts

• Principal investigator: Liu Xiaoqiang, Dr. — Yunnan Provincial Center for Disease Control and Prevention
• Study coordinator: Liu Xiaoqiang, Dr.

Conditions Hand, Foot, and Mouth Disease（HFMD); bivalent enterovirus inactivated vaccine; Hand, Foot, and Mouth Disease; EV71; CA16; PHASE Ⅲ; vaccine efficacy; immonogenicity