Status:
COMPLETED
A Phase II, Safety and Efficacy Study of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants
Lead Sponsor:
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborating Sponsors:
Guangxi Center for Disease Control and Prevention
Conditions:
The Study Focused on the Safety of Inactivated EV71 Vaccine (Human Diploid Cell) Against Hand, Foot and Mouth Disease in Chinese Children and Infants
Eligibility:
All Genders
6-5 years
Phase:
PHASE2
Brief Summary
Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Since the ...
Detailed Description
Hand-foot-and-mouth disease (HFMD) is a significant cause of death, usually characterized by vesicular lesions on the skin and oral mucosa and high morbidity rates in children. Additionally, occasiona...
Eligibility Criteria
Inclusion
- Healthy subjects (6-35 months infants) as established by medical history and clinical examination
- Full-term (37-42 weeks), weight ≥ 2500 g when it was born
- 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 2-month visit and receive blood tests according to program requirements
Exclusion
- Subject who has a clinical diagnosis history of Hand, Foot and Mouth Disease (HFMD)
- 37 weeks gestation
- weight ≤ 2500 g when it was born
- Allergy or serious side-effects to a vaccine or any ingredient of vaccine
- Epilepsy, seizures, convulsions, neurological illness
- Congenital or hereditary immunodeficiency
- Autoimmune disease
- Severe malnutrition or dysgenopathy
- 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 28 days or 1 months
- Any prior administration of subunit or inactivated vaccines in last 14 days Under the anti-TB prevention or therapy
- Fever before vaccination, axillary temperature ﹥37.0℃
- The laboratory test abnormalities before vaccination, including blood tests (hemoglobin, total white blood cells, WBC, platelets), blood biochemistry tests (ALT, total bilirubin, direct bilirubin, Cr, BUN) and urine tests (urine protein, urine sugar, blood cells), etc.
- Hypertension or hypotension. Systolic blood pressure ﹥140mmHg and/or diastolic blood pressure ﹥90mmHg; systolic blood pressure ﹤90mmHg and/or diastolic blood pressure ﹤60mmHg
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT01512706
Start Date
July 1 2011
End Date
February 1 2012
Last Update
October 11 2023
Active Locations (1)
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1
Guangxi Provincial Center for Diseases Control and Prevention
Nanning, Guangxi, China