An Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

Sinovac

Status and phase

Completed

Phase 3

Conditions

Hand, Foot and Mouth Disease

Treatments

Biological: 0/0.5ml placebo

Biological: 400U /0.5ml EV71 vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01507857

PRO-EV71-3001

Details and patient eligibility

About

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.

Full 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.

Enrollment

10,077 patients

Sex

All

Ages

6 to 35 months old

Volunteers

Accepts Healthy Volunteers

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