Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine

NCT06146088 | Recruiting Phase 4

• 1 other identifier: EV71-401
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 4

Brief Summary

This study is a randomized, blinded study to evaluate the lot-to-lot consistency of immunogenicity, safety, and immune persistence of three consecutive manufacturing lots of EV71 vaccine, in 1500 children aged 6-35 months. The primary immunogenicity endpoint is the anti-EV71 neutralizing antibody geometric mean titer (GMT) 30 days after the final dose. The secondary immunogenicity endpoints are the geometric mean fold increases and seroconversion rates of anti-EV71 neutralizing antibodies 30 days after the final dose. The immune persistence endpoints are the seropositive rates as well as GMT of anti-EV71 neutralizing antibodies 12 and 24 months after the final dose. The safety endpoints are the number of adverse events/reactions within 30 minutes after each dose, the number of solicited adverse events/reactions within 7 days after each dose, the number of unsolicited adverse events/reactions within 30 days after each dose, and the number of serious adverse events (SAE) from the first dose to 6 months post the final dose.

Conditions

Hand, Foot and Mouth Disease

Keywords

Enterovirus 71; Inactivated enterovirus 71 vaccine

Outcome Measures

Primary Outcomes (1)

• Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody

  Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method

  Day 30 after the second vaccination

Secondary Outcomes (10)

• Immunogenicity index-geometric mean fold increase (GMFI) of neutralizing antibody

  Between baseline and Day 30 after the second vaccination

• Immunogenicity index-seroconversion rates of neutralizing antibody

  Between baseline and Day 30 after the second vaccination

• Immunogenicity index-seropositive rates of neutralizing antibody

  Day 30, 12 months, and 24 months after the second vaccination

• Safety index-incidence of adverse reactions/events

  0-30 minutes after the first dose vaccination

• Safety index-incidence of adverse reactions/events

  0-30 minutes after the second dose vaccination

Study Arms (3)

Batch 1 (6-35 months old, 2 doses)

EXPERIMENTAL

Inactivated Enterovirus 71 Vaccine (human diploid cell) in children aged 6-35 months old on Day 0 and Day 30 approved by the National Institute for Food and Drug Control

Biological: EV71 Vaccine

Batch 2 (6-35 months old, 2 doses)

EXPERIMENTAL

Inactivated Enterovirus 71 Vaccine (human diploid cell) in children aged 6-35 months old on Day 0 and Day 30 approved by the National Institute for Food and Drug Control

Biological: EV71 Vaccine

Batch 3 (6-35 months old, 2 doses)

EXPERIMENTAL

Inactivated Enterovirus 71 Vaccine (human diploid cell) in children aged 6-35 months old on Day 0 and Day 30 approved by the National Institute for Food and Drug Control

Biological: EV71 Vaccine

Interventions

EV71 Vaccine BIOLOGICAL

Inactivated enterovirus 71 vaccine (human diploid cell) of 3.0EU/0.5mL on Day 0,30

Batch 1 (6-35 months old, 2 doses); Batch 2 (6-35 months old, 2 doses); Batch 3 (6-35 months old, 2 doses)

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.).
• Severe Adverse Reactions: Subjects experienced serious adverse reactions after receiving the previous vaccine dose.

Sponsors & Collaborators

• Institute of Medical Biology, Chinese Academy of Medical Sciences: lead
• Centers for Disease Control and Prevention, China: collaborator

Study Sites (4)

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

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Weijun Hu

CONTACT

029-82221350; huweijun0828@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: November 25, 2023
• Primary Completion: March 31, 2024
• Study Completion (Estimated): July 15, 2026
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)