Status:
UNKNOWN
The Phase IVc of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell)
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborating Sponsors:
Hubei Provincial Center for Disease Control and Prevention
Conditions:
Hand, Foot and Mouth Disease (HFMD)
Eligibility:
All Genders
6-71 years
Phase:
PHASE4
Brief Summary
Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to...
Detailed Description
There are two parts of phase IVc clinical trials have been performed. First, to evaluate the immunogenicity of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 mon...
Eligibility Criteria
Inclusion
- Healthy subjects (6-71 months old children) as established by medical history and clinical examination
- 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 14-month visit (and receive blood, stool (or specimens by means of a swab) tests according to program requirements in immunogenicity observation group)
Exclusion
- Allergy or serious side-effects to a vaccine or any ingredient of vaccine
- Epilepsy, seizures, convulsions, neurological illness
- Congenital or hereditary immunodeficiency
- Autoimmune disease
- 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 15 days
- Any prior administration of subunit or inactivated vaccines in last 7 days
- 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 ﹥140 mmHg and/ or diastolic blood pressure ﹥90 mmHg; systolic blood pressure ﹤90 mmHg and/or diastolic blood pressure ﹤60 mmHg
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- take part into other vaccine or drug clinical trials in last half year
Key Trial Info
Start Date :
June 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT03240744
Start Date
June 22 2017
End Date
October 1 2020
Last Update
September 6 2017
Active Locations (1)
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1
Hubei Province Center for Diseases Control and Prevention
Wuhan, Hubei, China