A Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months
NCT ID: NCT01508247
Last Updated: 2013-03-29
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
PHASE3
10245 participants
INTERVENTIONAL
2012-01-31
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The data from the phase 1 and 2 trials suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. According to the immunogenicity and safety results, the 320U with adjuvant with immunizing schedule of two doses (per 28 day) will be applied in phase 3 clinical trial.
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.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
vaccine against EV71
Inactivated vaccine (Vero Cell) against EV71 of 320U /0.5ml in 5000 children aged 6-35 months on day0, 28
inactivated vaccine (Vero Cell) against EV71
inactivated vaccine (vero cell) against EV71, 320U /0.5ml, two doses, on day0, 28
placebo
0/0.5ml placebo in 5000 children aged 6-35 months on day0, 28
0/0.5ml placebo
0/0.5ml placebo, two doses, on day0, 28
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
inactivated vaccine (Vero Cell) against EV71
inactivated vaccine (vero cell) against EV71, 320U /0.5ml, two doses, on day0, 28
0/0.5ml placebo
0/0.5ml placebo, two doses, on day0, 28
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthy children aged from 6 to 35 months old
* General good health as established by medical history and physical examination
* The subjects' guardians are able to understand and sign the informed consent
* Had never received the vaccine against EV71
* The subjects' guardians allow to comply with the requirements of the protocol
* Available for all visits scheduled in this study
* Subjects with temperature \<=37.0°C on axillary setting
Exclusion Criteria
* Subject who has a medical history of HFMD
* Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
* Family history of seizures or progressive neurological disease
* Family history of congenital or hereditary immunodeficiency
* Severe malnutrition or hypogenesis
* Major congenital defects or serious chronic illness, including perinatal brain damage
* Autoimmune disease
* Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
* Asplenia, functional asplenia, or splenic excision
* History of asthma, angioneurotic edema, diabetes or malignant tumour
* History of thyroidectomy, or thyroid disease in last 12 months
* Any acute infections in last 7 days
* Any prior administration of immunodepressant or corticosteroids in last 6 months
* Any prior administration of blood products in last 3 months
* Any prior administration of other research vaccines or medicines in last 1 month
* Any prior administration of attenuated live vaccine in last 15 days
* Any prior administration of subunit or inactivated vaccines in last 7 days
* Under the anti-TB prevention or therapy
* Subjects with temperature \>37.0°C on axillary setting
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Subjects will not be eligible for the second dose if any of following adverse events happened after the first dose. They can continue other process of the study without the second dose vaccination according to the opinion of the investigator.
* Had any serious adverse events related to the first dose of inactivated vaccine (vero cell) against EV71 within 7 days
* Hypersensitivity reactions after vaccination (including urticaria/rashes that occur within 30 minutes after inoculation)
* Anaphylaxis after vaccination
* Any confirmed or suspected autoimmune disease or immune deficiency diseases, including human immunodeficiency virus (HIV) infection
* Any condition that in the opinion of the investigator, or IRB
6 Months
35 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bejing Vigoo Biological Co., LTD
INDUSTRY
Jiangsu Province Centers for Disease Control and Prevention
NETWORK
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.
Feng-Cai Zhu, Master
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial Center for Diseases Control and Prevention
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Donghai County Center for Disease Control and Prevention
Lianyungang, Jiangsu, China
Pizhou County-Level City Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
Baoying County Center for Disease Control and Prevention
Yangzhou, Jiangsu, China
Chaoyang Distinct Center for Disease Control and Prevention
Beijing, , 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.
Zhu W, Jin P, Li JX, Zhu FC, Liu P. Correlates of protection for inactivated enterovirus 71 vaccine: the analysis of immunological surrogate endpoints. Expert Rev Vaccines. 2017 Sep;16(9):945-949. doi: 10.1080/14760584.2017.1335603. Epub 2017 Jun 12.
Wei M, Meng F, Wang S, Li J, Zhang Y, Mao Q, Hu Y, Liu P, Shi N, Tao H, Chu K, Wang Y, Liang Z, Li X, Zhu F. 2-Year Efficacy, Immunogenicity, and Safety of Vigoo Enterovirus 71 Vaccine in Healthy Chinese Children: A Randomized Open-Label Study. J Infect Dis. 2017 Jan 1;215(1):56-63. doi: 10.1093/infdis/jiw502. Epub 2016 Oct 17.
Zhu FC, Meng FY, Li JX, Li XL, Mao QY, Tao H, Zhang YT, Yao X, Chu K, Chen QH, Hu YM, Wu X, Liu P, Zhu LY, Gao F, Jin H, Chen YJ, Dong YY, Liang YC, Shi NM, Ge HM, Liu L, Chen SG, Ai X, Zhang ZY, Ji YG, Luo FJ, Chen XQ, Zhang Y, Zhu LW, Liang ZL, Shen XL. Efficacy, safety, and immunology of an inactivated alum-adjuvant enterovirus 71 vaccine in children in China: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2013 Jun 8;381(9882):2024-32. doi: 10.1016/S0140-6736(13)61049-1. Epub 2013 May 29.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JSVCT010
Identifier Type: -
Identifier Source: org_study_id