- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06146088
Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Weijun Hu
- Phone Number: +86 029-82221350
- Email: huweijun0828@163.com
Study Locations
-
-
Shaan XI
-
Baoji, Shaan XI, China
- Not yet recruiting
- Chencang Center for Disease Prevention and Control
-
Contact:
- MIn Yang
- Phone Number: +86 0917-6298067
- Email: ccqcdcfy@163.com
-
Hanzhong, Shaan XI, China
- Recruiting
- Ningqiang Center for Disease Prevention and Control
-
Contact:
- Hui Zhang
- Phone Number: +86 0916-4228039
- Email: 412111748@qq.com
-
Weinan, Shaan XI, China
- Not yet recruiting
- Fuping Center for Disease Prevention and Control
-
Contact:
- liqi Shi
- Phone Number: +86 0913-8212134
- Email: 469001182@qq.com
-
Xianyang, Shaan XI, China
- Recruiting
- Jingyang Center for Disease Prevention and Control
-
Contact:
- Xiaohua Zhai
- Phone Number: 029-36212531
- Email: jingyangcdc@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Batch 1 (6-35 months old, 2 doses)
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
|
Inactivated enterovirus 71 vaccine (human diploid cell) of 3.0EU/0.5mL
on Day 0,30
|
Experimental: Batch 2 (6-35 months old, 2 doses)
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
|
Inactivated enterovirus 71 vaccine (human diploid cell) of 3.0EU/0.5mL
on Day 0,30
|
Experimental: Batch 3 (6-35 months old, 2 doses)
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
|
Inactivated enterovirus 71 vaccine (human diploid cell) of 3.0EU/0.5mL
on Day 0,30
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Time Frame: Day 30 after the second vaccination
|
Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method
|
Day 30 after the second vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity index-geometric mean fold increase (GMFI) of neutralizing antibody
Time Frame: Between baseline and Day 30 after the second vaccination
|
Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method
|
Between baseline and Day 30 after the second vaccination
|
Immunogenicity index-seroconversion rates of neutralizing antibody
Time Frame: Between baseline and Day 30 after the second vaccination
|
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
|
Immunogenicity index-seropositive rates of neutralizing antibody
Time Frame: Day 30, 12 months, and 24 months after the second vaccination
|
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
|
Safety index-incidence of adverse reactions/events
Time Frame: 0-30 minutes after the first dose vaccination
|
Incidence of adverse reactions/events after the first dose vaccination
|
0-30 minutes after the first dose vaccination
|
Safety index-incidence of adverse reactions/events
Time Frame: 0-30 minutes after the second dose vaccination
|
Incidence of adverse reactions/events after the second dose vaccination
|
0-30 minutes after the second dose vaccination
|
Safety index-incidence of adverse reactions/events
Time Frame: Day 0 to Day 7 after the first dose vaccination
|
Incidence of solicited adverse reactions/events after the first dose vaccination
|
Day 0 to Day 7 after the first dose vaccination
|
Safety index-incidence of adverse reactions/events
Time Frame: Day 0 to Day 7 after the second dose vaccination
|
Incidence of solicited adverse reactions/events after the second dose vaccination
|
Day 0 to Day 7 after the second dose vaccination
|
Safety index-incidence of adverse reactions/events
Time Frame: Day 0 to Day 30 after the first dose vaccination
|
Incidence of unsolicited adverse reactions/events after the first dose vaccination
|
Day 0 to Day 30 after the first dose vaccination
|
Safety index-incidence of adverse reactions/events
Time Frame: Day 0 to Day 30 after the second dose vaccination
|
Incidence of unsolicited adverse reactions/events after the second dose vaccination
|
Day 0 to Day 30 after the second dose vaccination
|
Safety index-incidence of serious adverse reactions/events
Time Frame: From the first dose to 6 months post the last dose of vaccination completed
|
Occurrence of serious adverse reactions/events after vaccination
|
From the first dose to 6 months post the last dose of vaccination completed
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EV71-401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hand, Foot and Mouth Disease
-
Oxford University Clinical Research Unit, VietnamChildren's Hospital Number 1, Ho Chi Minh City, Vietnam; Hospital for Tropical... and other collaboratorsCompletedHand Foot and Mouth DiseaseVietnam
-
International Centre for Diarrhoeal Disease Research...CompletedHand Foot & Mouth DiseaseBangladesh
-
Children's Hospital of Fudan UniversityWeihai Rensheng PharmacyCompleted
-
Beijing Chaoyang District Centre for Disease Control...Unknown
-
Institute of Medical Biology, Chinese Academy of...Hubei Provincial Center for Disease Control and PreventionCompletedThe Phase IVb of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese ChildrenHand, Foot and Mouth Disease (HFMD)China
-
Cancer Institute and Hospital, Chinese Academy...Hubei Provincial Center for Disease Control and PreventionUnknownHand, Foot and Mouth Disease (HFMD)China
-
Cancer Institute and Hospital, Chinese Academy...Guangdong Center for Disease Prevention and ControlUnknown
-
Eskisehir Osmangazi UniversityAbdi Ibrahim Ilac San. ve Tic A.S.CompletedHand, Foot, and Mouth DiseaseTurkey
-
Jiangsu Province Centers for Disease Control and...Bejing Vigoo Biological Co., LTDCompletedEnterovirus Infections | Hand, Foot, and Mouth DiseaseChina
-
Jiangxi Qingfeng Pharmaceutical Co. Ltd.Beijing YouAn Hospital; China Academy of Chinese Medical Sciences; Beijing University... and other collaboratorsCompletedHand, Foot, and Mouth DiseaseChina
Clinical Trials on EV71 Vaccine
-
Sinovac Biotech Co., LtdCompletedInfection, Viral, EnterovirusChina
-
National Health Research Institutes, TaiwanCompleted
-
China National Biotec Group Company LimitedPeking University; Wuhan Institute of Biological Products Co., Ltd; Guizhou Center... and other collaboratorsCompletedEnterovirus Infections | InfluenzaChina
-
Medigen Vaccine Biologics Corp.Completed
-
Sinovac Biotech Co., LtdCompletedHand, Foot and Mouth DiseaseChina
-
Jiangsu Province Centers for Disease Control and...Wuhan Institute of Biological Products Co., Ltd; Hubei Provincial Center for...CompletedHand, Foot and Mouth DiseaseChina
-
Sinovac Biotech Co., LtdZhejiang Provincial Center for Disease Control and Prevention; Shangyu District...CompletedHand, Foot and Mouth DiseaseChina
-
Enimmune CorporationEnrolling by invitationEnterovirus InfectionsTaiwan, Vietnam
-
Jiangsu Province Centers for Disease Control and...Bejing Vigoo Biological Co., LTDCompletedHand, Foot and Mouth Disease
-
Cancer Institute and Hospital, Chinese Academy...Guangdong Center for Disease Prevention and ControlUnknown