UnknownPhase 4

The Phase IVc of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell)

China800 participantsStarted 2017-06-22

Plain-language summary

Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to severe diseases and death, with central nervous system (CNS) damage. Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, such as attenuated vaccine, subunit vaccine. A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016. The purpose of phase IVc is to evaluated the immunogenicity of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old) in Hubei Province, China.

Who can participate

Age range6 Months – 71 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy subjects (6-71 months old children) as established by medical history and clinical examination * The subjects' legal guardian must be aware of this vaccines * The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form * Subjects with temperature ≤ 37.0 ℃ * The subjects' legal guardian with the ability and objective to comply with the requirements of the protocol * Persist for a 14-month visit (and receive blood, stool (or specimens by means of a swab) tests according to program requirements in immunogenicity observation group) Exclusion Criteria: * Allergy or serious side-effects to a vaccine or any ingredient of vaccine * Epilepsy, seizures, convulsions, neurological illness * Congenital or hereditary immunodeficiency * Autoimmune disease * Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer * Asplenia, functional asplenia, and any circumstances leading to the asplenia or splenectomy * Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder * Acute illness or acute exacerbation of chronic disease 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 live-attenuated vaccine in last 15 days * Any prior administration of subunit or inactivated vaccines…

What they're measuring

Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children

Timeframe: at 28 days after finishing 2 doses immunization

Evaluate the antibody titers of anti-EV71 antibodies in serum of children

Timeframe: at 28 days after finishing 2 doses immunization

Trial details

NCT IDNCT03240744

SponsorChinese Academy of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10