Immunogenicity and Safety of Two Different Commercial EV71 Vaccines
NCT ID: NCT03873740
Last Updated: 2021-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2018-11-06
2019-01-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine
NCT01636245
An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
NCT01507857
Phase IV Clinical Trial, Immunogenicity and Safety of EV71 Vaccine
NCT03278132
Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
NCT03893747
A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
NCT02001233
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single vaccine group A
This group receive two doses injection of EV71 inactived vaccines(Vero cells) on Day 0 and 30, and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.The vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd.
EV71 inactived vaccine（Vero cells）
The EV71 inactived vaccine（Vero cells） was manufactured by Sinovac Biotech Co., Ltd.
Single vaccine group B
This group receive two doses injection of EV71 inactived vaccines(human diploid cells)on Day 0 and 30, two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.The vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
EV71 inactived vaccine（Human diploid cells）
The EV71 inactived vaccine（Human diploid cells） was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
Sequential vaccination group A
One dose injection of EV71 inactived vaccines(Vero cells) on Day 0，following one dose of EV71 vaccine(EV71 inactived vaccines(human diploid cells), and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.
EV71 inactived vaccine（Vero cells）
The EV71 inactived vaccine（Vero cells） was manufactured by Sinovac Biotech Co., Ltd.
EV71 inactived vaccine（Human diploid cells）
The EV71 inactived vaccine（Human diploid cells） was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
Sequential vaccination group B
One dose injection of EV71 inactived vaccines(human diploid cells)on Day 0，following one does of EV71 vaccine(Sinovac Vaccine Technology Co., Ltd), and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.
EV71 inactived vaccine（Vero cells）
The EV71 inactived vaccine（Vero cells） was manufactured by Sinovac Biotech Co., Ltd.
EV71 inactived vaccine（Human diploid cells）
The EV71 inactived vaccine（Human diploid cells） was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EV71 inactived vaccine（Vero cells）
The EV71 inactived vaccine（Vero cells） was manufactured by Sinovac Biotech Co., Ltd.
EV71 inactived vaccine（Human diploid cells）
The EV71 inactived vaccine（Human diploid cells） was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Proven legal identity;
* Guardians of the participants should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study.
Exclusion Criteria
* History of hand，foot and mouth disease;
* Allergy to gentamicin; history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria,difficulty in breathing, angioneurotic edema, pain, etc;
* Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
* Autoimmune diseases or immunodeficiency/immunosuppression;
* Severe neurological disorders (epilepsy, convulsions or convulsions) or psychosis;
* History of thyroidectomy, absence of spleen, functional absence of spleen, and any circumstances leading to absence of spleen or splenectomy;
* Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
* Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) in the past 6 months;
* Receipt of any of the following products:
1. Blood product within 3 months prior to study entry;
2. Any live attenuated vaccine within 14 days prior to study entry;
3. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
4. Any other study drugs within 30 days prior to study entry;
* Acute disease or acute stage of chronic disease within 7 days prior to study entry;
* Axillary temperature \> 37.0℃;
* Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.
6 Months
35 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shandong Province Centers for Disease Control and Prevention
OTHER
Sinovac Biotech Co., Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
AIqiang Xu
Role: PRINCIPAL_INVESTIGATOR
Shandong Provincal Center for Disease Control and Preventione
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rushan City Center for Disease Control and Prevention
Xiacun, Shandong, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Xu Q, Cao Q, Yang W, Liu X, Liu H, Tian X, Li J, Fang X, Jia N, Zeng G, Xu A. Interchangeability of two Enterovirus 71 inactivated vaccines in Chinese children: A phase IV, open-label, and randomized controlled trial. Vaccine. 2020 Mar 10;38(12):2671-2677. doi: 10.1016/j.vaccine.2020.02.013. Epub 2020 Feb 14.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EV71-SD-2018-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.