Status:
COMPLETED
A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Collaborating Sponsors:
Bejing Vigoo Biological Co., LTD
Conditions:
Immunogenicity
Safety
Eligibility:
All Genders
6-36 years
Phase:
PHASE2
Brief Summary
Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do no...
Eligibility Criteria
Inclusion
- For children group (aged from 12-36 months):
- Healthy children aged from 12 to 36 months old as established by medical history and clinical examination
- The subjects' guardians are able to understand and sign the informed consent
- Had never received the vaccine against EV71
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature \<=37.0°C on axillary setting
- For infants group (aged from 6-11 months):
- Healthy infants aged from 6 to 11 months old as established by medical history and clinical examination
- The subjects' guardians are able to understand and sign the informed consent
- Had never received the vaccine against EV71
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature \<=37.0°C on axillary setting
Exclusion
- For children group (aged from 12-36 months):
- Subject who has a medical history of HFMD
- \<= 37 weeks gestation
- Subjects with a birth weight \<2.5 kg
- 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 dysgenopathy
- 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
- Any acute infections in last 7 days
- Any prior administration of immunodepressant or corticosteroids in last 6month
- Any prior administration of blood products in last 3 month
- Any prior administration of other research medicines in last 1 month
- Any prior administration of attenuated live vaccine in last 28 days
- Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
- Under the anti-TB prevention or therapy
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- For infants group (aged from 6-11 months):
- Subject who has a medical history of HFMD
- \<= 37 weeks gestation
- Subjects with a birth weight \<2.5 kg
- 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 dysgenopathy
- 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
- Any acute infections in last 7 days
- Any prior administration of immunodepressant or corticosteroids in last 6month
- Any prior administration of blood products in last 3 month
- Any prior administration of other research medicines in last 1 month
- Any prior administration of attenuated live vaccine in last 28 days
- Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
- Under the anti-TB prevention or therapy
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- Exclusion Criteria for the second dose:
- Had any Grade 3 or Grade 4 adverse reaction within 7 days after first dose
- Any situation meet the exclusion criteria stated in the exclusion criteria for first dose
- Had any SAE related to first dose during the following-up of first dose
- Any condition that in the opinion of the investigator, or IRB
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT01399853
Start Date
July 1 2011
End Date
May 1 2012
Last Update
May 31 2012
Active Locations (1)
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1
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210009