Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06146088
Other study ID # EV71-401
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 25, 2023
Est. completion date July 15, 2026

Study information

Verified date January 2024
Source Institute of Medical Biology, Chinese Academy of Medical Sciences
Contact Weijun Hu
Phone 029-82221350
Email huweijun0828@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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 children aged 6-35 months. The study is conducted to enroll 1500 healthy participants, including 600 infants aged 6-11 months, 600 toddlers aged 12-23 months, and 300 children aged 24-35 months. Eligibility will be assessed through medical history and physical examination. Participants from each age group will be randomly assigned to three different batch groups in a ratio of 1:1:1, that is, 500 participants in total will be in each lot arm, respectively. All participants will receive an injection of the EV71 vaccine in the anterolateral midthigh or deltoid muscle of the upper arm on Day 0 and Day 30, respectively. The duration of interventions for each participant is approximately 1 month, thus, the duration of the immune persistence study for each participant is approximately 25 months. For immunogenicity and immune persistence assessment, neutralizing antibodies against EV71 of all participants will be assessed on the first day (Day 0) before administration, 30 days after the final dose, and 12 and 24 months after the final dose, respectively. For safety assessment, observation of adverse events (AE) from Day 0 to Day 30 after each dose of vaccination will be evaluated by diary or contact cards. Simultaneously, the serious adverse event (SAE) between the first dose of the vaccine to 6 months after the final dose will be evaluated by diary or contact cards, active reports, investigators' phone calls, or on-site visits. Meanwhile, participants will be observed at clinical sites for at least 30 minutes.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date July 15, 2026
Est. primary completion date March 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 35 Months
Eligibility 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.

Study Design


Intervention

Biological:
EV71 Vaccine
Inactivated enterovirus 71 vaccine (human diploid cell) of 3.0EU/0.5mL on Day 0,30

Locations

Country Name City State
China Chencang Center for Disease Prevention and Control Baoji Shaan XI
China Ningqiang Center for Disease Prevention and Control Hanzhong Shaan XI
China Fuping Center for Disease Prevention and Control Weinan Shaan XI
China Jingyang Center for Disease Prevention and Control Xianyang Shaan XI

Sponsors (2)

Lead Sponsor Collaborator
Institute of Medical Biology, Chinese Academy of Medical Sciences Shanxi Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Immunogenicity index-geometric mean fold increase (GMFI) of neutralizing antibody Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method Between baseline and Day 30 after the second vaccination
Secondary Immunogenicity index-seroconversion rates of neutralizing antibody Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method.
Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (=1:8), or =4-fold increase from baseline
Between baseline and Day 30 after the second vaccination
Secondary Immunogenicity index-seropositive rates of neutralizing antibody Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method. Seropositive will be defined as the positive results with ties=1:8 Day 30, 12 months, and 24 months after the second vaccination
Secondary Safety index-incidence of adverse reactions/events Incidence of adverse reactions/events after the first dose vaccination 0-30 minutes after the first dose vaccination
Secondary Safety index-incidence of adverse reactions/events Incidence of adverse reactions/events after the second dose vaccination 0-30 minutes after the second dose vaccination
Secondary Safety index-incidence of adverse reactions/events Incidence of solicited adverse reactions/events after the first dose vaccination Day 0 to Day 7 after the first dose vaccination
Secondary Safety index-incidence of adverse reactions/events Incidence of solicited adverse reactions/events after the second dose vaccination Day 0 to Day 7 after the second dose vaccination
Secondary Safety index-incidence of adverse reactions/events Incidence of unsolicited adverse reactions/events after the first dose vaccination Day 0 to Day 30 after the first dose vaccination
Secondary Safety index-incidence of adverse reactions/events Incidence of unsolicited adverse reactions/events after the second dose vaccination Day 0 to Day 30 after the second dose vaccination
Secondary Safety index-incidence of serious adverse reactions/events Occurrence of serious adverse reactions/events after vaccination From the first dose to 6 months post the last dose of vaccination completed
See also
  Status Clinical Trial Phase
Recruiting NCT06063057 - Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial Phase 1/Phase 2
Completed NCT04133584 - The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine Phase 4
Completed NCT03241030 - Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial Phase 2
Completed NCT01255124 - Study on Dynamic Changes of the Maternal Anti-EV71 and Anti-CVA16 Antibody Levels in Infants and Young Children N/A
Completed NCT03873740 - Immunogenicity and Safety of Two Different Commercial EV71 Vaccines Phase 4
Completed NCT05637229 - A Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia
Active, not recruiting NCT06209398 - Immunogenicity of the Inactivated EV71 Vaccine Combined With Hepatitis B and Group A Meningococcal Vaccine Phase 4
Recruiting NCT01175915 - A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease N/A
Recruiting NCT01145664 - A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease N/A
Completed NCT01182532 - A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease N/A
Completed NCT03281174 - Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine N/A
Completed NCT03582761 - Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71 Phase 4
Completed NCT03903926 - Efficacy Trial of a Commercial EV71 Vaccine Phase 4
Completed NCT02001233 - A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
Completed NCT03909074 - Clinical Trial of Enterovirus 71(EV71) Inactivated Vaccine in Children Aged 36-71 Months Phase 3
Completed NCT01769794 - Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study N/A
Recruiting NCT01182025 - A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease N/A
Recruiting NCT06263439 - Surveillance of HFMD in Pediatric Outpatients
Not yet recruiting NCT05397587 - An Immunity Persistence Study of Enterovirus 71 Inactivated Vaccine (Vero Cell) Phase 4
Completed NCT04111432 - Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines Phase 4