A Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months

Jiangsu Provincial Center for Disease Control and Prevention

Status and phase

Completed

Phase 3

Conditions

Herpangina

Other EV71-associated Diseases

Hand, Foot and Mouth Disease

Treatments

Biological: inactivated vaccine (Vero Cell) against EV71

Biological: 0/0.5ml placebo

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT01508247

JSVCT010

Details and patient eligibility

About

Since its discovery in 1969, enterovirus 71 (EV71) has been recognised as a frequent cause of epidemics of hand-foot-mouth disease (HFMD) associated with severe neurological sequelae in a small proportion of cases. There has been a significant increase in EV71 epidemic activity throughout the Asia-Pacific region since 1997. Recent HFMD epidemics in this region have heen associated with a severe from of brainstem encephalitis associated with pulmonary oedema and high case-fatality rates.

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.

Enrollment

10,245 patients

Sex

All

Ages

6 to 35 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Only subjects fulfilling all of the following criteria will be eligible for the study:

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

Subjects will not be eligible for the study if any of the following criteria is met:

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

Exclusion Criteria for the second dose:

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