Evaluating consistency of three batches of EV71 vaccine in young children

To Evaluate the Lot-to-lot Consistency of Immunogenicity, Safety, and Immune Persistence of Three Consecutive Commercial Manufacturing Batches of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell) in Children Aged 6-35 Months in a Randomized, Blinded Study

This study is testing whether three different batches of the EV71 vaccine are safe and effective for children aged 6 to 35 months.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1500 (estimated)
• Ages: 6 Months to 35 Months
• Sex: All
• Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: prednisone
• Locations: 4 sites (Baoji, Shaan XI and 3 other locations)
• Trial ID: NCT06146088 on ClinicalTrials.gov

What this trial studies

This randomized, blinded study aims to assess the lot-to-lot consistency of immunogenicity, safety, and immune persistence of three consecutive manufacturing lots of the Enterovirus 71 (EV71) vaccine in 1500 children aged 6 to 35 months. Participants will be randomly assigned to receive one of the three vaccine batches, with immunogenicity evaluated through neutralizing antibody levels at various time points after vaccination. Safety will be monitored through the reporting of adverse events following vaccination, and immune persistence will be assessed over a 24-month period post-vaccination.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy children aged 6 to 35 months who meet the inclusion criteria.

Not a fit: Patients with a history of allergies to any components of the vaccine or those with certain medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could ensure the reliability and effectiveness of the EV71 vaccine, potentially reducing the incidence of Hand, Foot and Mouth Disease in young children.

How similar studies have performed: Other studies evaluating vaccine consistency have shown promising results, indicating that this approach is supported by previous research.

Eligibility criteria

Inclusion Criteria:

* Age Requirement: Children aged 6 to 35 months at the time of enrollment.
* Provision of legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
* Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the study's requirements and complete relevant visits on time.
* Temperature Requirement: Axillary body temperature prior to vaccination is less than 37.3°C.

Exclusion Criteria:

\[First Dose Exclusion Criterions\] Subjects meeting any of the following exclusion criteria will not be eligible for enrollment

* Allergic History: Subjects have a previous history of allergies to any component of the vaccine (e.g., aluminum hydroxide, glycine), or previous or suspected allergy to any vaccine or other serious adverse reaction (e.g., anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction, dyspnea, angioedema, systemic rash and/or urticaria, etc.).
* Vaccination History: Subjects received any inactivated vaccine or subunit vaccine within 7 days prior to the first dose of the investigational vaccine or any live attenuated vaccine within 14 days prior to the first dose of the investigational vaccine.
* Neurological and Mental Health: Subjects with a history or family history of convulsion, epilepsy, encephalopathy, and psychosis.
* Health Conditions: Subjects with known severe congenital malformation or developmental disorder (e.g., Down syndrome, sickle cell anemia, congenital neurological disorders).
* Acute Illness: Subjects have experienced acute illness (e.g., fever) or acute onset of chronic illness within 3 days before the first dose of investigational vaccine, or use of antipyretic, analgesic, or antiallergic drugs within 3 days before the first dose of the investigational vaccine.
* Coagulation Abnormalities: Subjects with genetic bleeding tendency, coagulopathy, or a history of bleeding disorders.
* Organ Removal History: Subjects have a history of surgical removal of the spleen or other vital immune organs for any reason.
* Blood Conditions: Subjects with blood loss (≥400mL) or receipt of blood transfusion, immune globulin (other than hepatitis B immune globulin), or blood products within 3 months prior to the first dose of the investigational vaccine.
* Drug Administration: Subjects use any investigational or unregistered product (drug, biological product, or device) within 3 months prior to the first dose of the investigational vaccine, or planned use during the study, except the investigational vaccine.
* Immune Therapy: Subjects have a treatment with immunosuppressive agents within 6 months before the first dose of the investigational vaccine, such as long-term treatment with systemic glucocorticoids (e.g., prednisone or a similar agent for more than 2 consecutive weeks within 6 months), but topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) would be allowed.
* Previous history of receipt of other EV71 vaccines.
* Previous history of hand-foot-mouth disease.
* Immune-related Disease: Subjects have been diagnosed with an infectious disease that may interfere with the conduct or completion of the study (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus infection, etc.).
* Investigators' Discretion: The final exclusion criterion is the investigator's discretion to determine whether a subject is suitable for participation in the study.

\[Contraindication of the second dose of vaccine\] Subjects meeting any of the following exclusion criteria will not be eligible for the second dose of the investigational vaccine

* Meeting allergic conditions that are mentioned in the First Dose Exclusion Criteria after the first dose.
* Severe Adverse Reactions: Subjects experienced serious adverse reactions after receiving the previous vaccine dose.
* Other Exclusion Reasons as Determined by the Investigator: The investigator determines other reasons for exclusion.

Where this trial is running

Baoji, Shaan XI and 3 other locations

• Chencang Center for Disease Prevention and Control — Baoji, Shaan XI, China (Not_yet_recruiting)
• Ningqiang Center for Disease Prevention and Control — Hanzhong, Shaan XI, China (Recruiting)
• Fuping Center for Disease Prevention and Control — Weinan, Shaan XI, China (Not_yet_recruiting)
• Jingyang Center for Disease Prevention and Control — Xianyang, Shaan XI, China (Recruiting)

Study contacts

• Study coordinator: Weijun Hu

Conditions Hand, Foot and Mouth Disease; Enterovirus 71; Inactivated enterovirus 71 vaccine