Clinical trial NCT01507857: An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
Official title: A Multicentered, Double - Blind, Randomized, and Placebo - Controlled Clinical Trial With Inactivated Enterovirus Type 71 (EV71) Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hand, Foot and Mouth Disease
Keywords: EV71 vaccine
HFMD
efficacy
EV71 associated disease
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2012-01-11
Enrollment: 10077
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.

Detailed description: The phase II study of inactivated vaccine (vero cell) against EV71 has completed on Dec 2011 in China. The data from the phase I and II study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. In order to evaluate the efficacy of the vaccine against Hand, Foot and Mouth disease caused by EV71, and to further explore the safety profile of this vaccine in expending infant population, a phase III clinical trial is planed to conduct.

Eligibility criteria: Inclusion Criteria:

* Healthy males and females, aged from 6 months to 11 years old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator
* Provided legal identification for the sake of recruitment
* Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents

Exclusion Criteria:

* History of Hand-foot-mouth Disease
* Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
* Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
* Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
* Epilepsy, seizures or convulsions history, or family history of mental illness
* Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
* History of asthma, angioedema, diabetes or malignancy
* History of thyroidectomy or thyroid disease that required medication within the past 12 months
* Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
* Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
* Acute illness or acute exacerbation of chronic disease within the past 7 days
* Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
* History of any blood products within 3 months
* Administration of any live attenuated vaccine within 14 days
* Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 7 days
* Axillary temperature \> 37.0 centigrade before vaccination
* Abnormal laboratory parameters before vaccination
* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

Primary outcomes:
measure: The incidence rate of Hand, Foot and Mouth disease caused by EV71 within one year observation period after the second vaccination
timeFrame: From 28 days after the second vaccination to one year
Secondary outcomes:
measure: The GMT of anti-EV71 antibodies in serum after second vaccination
timeFrame: 28 days after first vaccination
measure: The GMT of anti-EV71 antibodies in serum 7 and 13 months after second vaccination
timeFrame: 7 and 13 months after second vaccination
measure: Frequency of systemic and local adverse reactions after the first vaccination
timeFrame: 28 days after the first vaccination
measure: Frequency of systemic and local adverse reactions after the second vaccination
timeFrame: 28 days after the second vaccination
Other outcomes:
Locations:
city: Lianyungang
country: China
facility: Ganyu
state: Jiangsu
city: Taizhou
country: China
facility: Taixing
state: Jiangsu
city: Yancheng
country: China
facility: Sheyang CDC
state: Jiangsu
Study officials:
affiliation: Jiangsu Center for Diseases Control and Prevention
name: Hua Wang, BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu F, Xu W, Xia J, Liang Z, Liu Y, Zhang X, Tan X, Wang L, Mao Q, Wu J, Hu Y, Ji T, Song L, Liang Q, Zhang B, Gao Q, Li J, Wang S, Hu Y, Gu S, Zhang J, Yao G, Gu J, Wang X, Zhou Y, Chen C, Zhang M, Cao M, Wang J, Wang H, Wang N. Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China. N Engl J Med. 2014 Feb 27;370(9):818-28. doi: 10.1056/NEJMoa1304923.
citation: Chong P, Hsieh SY, Liu CC, Chou AH, Chang JY, Wu SC, Liu SJ, Chow YH, Su IJ, Klein M. Production of EV71 vaccine candidates. Hum Vaccin Immunother. 2012 Dec 1;8(12):1775-83. doi: 10.4161/hv.21739. Epub 2012 Sep 19.