Status:
COMPLETED
A Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Collaborating Sponsors:
Bejing Vigoo Biological Co., LTD
Conditions:
Hand, Foot and Mouth Disease
Herpangina
Eligibility:
All Genders
6-35 years
Phase:
PHASE3
Brief Summary
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 propor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
10245 Patients enrolled
Trial Details
Trial ID
NCT01508247
Start Date
January 1 2012
End Date
March 1 2013
Last Update
March 29 2013
Active Locations (4)
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1
Donghai County Center for Disease Control and Prevention
Lianyungang, Jiangsu, China
2
Pizhou County-Level City Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
3
Baoying County Center for Disease Control and Prevention
Yangzhou, Jiangsu, China
4
Chaoyang Distinct Center for Disease Control and Prevention
Beijing, China