A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
NCT ID: NCT01399853
Last Updated: 2012-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
1200 participants
INTERVENTIONAL
2011-07-31
2012-05-31
Brief Summary
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The phase I study of inactivated vaccine (vero cell) against EV71 has completed last month in Jiangsu Province in China. The data from the phase I study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. In order to provide more evidence for the immunogenicity of the vaccine, to further explore the probable immunizing dose and the safety profile of this vaccine, a phase II clinical trial is planed to conduct.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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160U /0.5ml in children (from 12 to 36 months old)
inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 120 children aged 12-36 months old on day0,28
160U /0.5ml EV71 Vaccine
inactivated vaccine (vero cell) against EV71 of 160U /0.5ml, two doses, 28 days interval
320U /0.5ml in children (from 12 to 36 months old)
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 120 children aged 12-36 months old on day0,28
320U /0.5ml EV71 vaccine
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 28 days interval
640U /0.5ml in children (from 12 to 36 months old)
inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 120 children aged 12-36 months old on day0,28
640U /0.5ml EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 640U /0.5ml, two doses, 28 days interval
(without adjuvant) 640U /0.5ml in children (12-36months)
inactivated vaccine(vero cell) against EV71 of (without adjuvant) 640U /0.5ml in 120 children aged 12-36 months old on day0,28
(without adjuvant) 640U /0.5ml
inactivated vaccine (vero cell) against EV71 of (without adjuvant) 640U /0.5ml, two doses, 28 days interval
160U /0.5ml in infants (from 6 to 11 months old)
inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 120 infants aged 6-11 months old on day0,28
160U /0.5ml EV71 Vaccine
inactivated vaccine (vero cell) against EV71 of 160U /0.5ml, two doses, 28 days interval
320U /0.5ml in infants (from 6 to 11 months old)
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 120 infants aged 6-11 months old on day0,28
320U /0.5ml EV71 vaccine
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 28 days interval
640U /0.5ml in infants (from 6 to 11 months old)
inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 120 infants aged 6-11 months old on day0,28
640U /0.5ml EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 640U /0.5ml, two doses, 28 days interval
(without adjuvant) 640U /0.5ml in infants (from 6 to 11 months
inactivated vaccine(vero cell) against EV71 of (without adjuvant) 640U /0.5ml in 120 infants aged 6-11 months old on day0,28
(without adjuvant) 640U /0.5ml
inactivated vaccine (vero cell) against EV71 of (without adjuvant) 640U /0.5ml, two doses, 28 days interval
0/0.5ml placebo in children (from 12 to 36 months old)
0/0.5ml placebo in 120 children aged 12-36 months old on day0,28
0/0.5ml placebo
0/0.5ml placebo, two doses, 28 days interval
0/0.5ml placebo in infants (from 6 to 11 months old)
0/0.5ml placebo in 120 infants aged 6-11 months old on day0,28
0/0.5ml placebo
0/0.5ml placebo, two doses, 28 days interval
Interventions
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160U /0.5ml EV71 Vaccine
inactivated vaccine (vero cell) against EV71 of 160U /0.5ml, two doses, 28 days interval
320U /0.5ml EV71 vaccine
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 28 days interval
640U /0.5ml EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 640U /0.5ml, two doses, 28 days interval
(without adjuvant) 640U /0.5ml
inactivated vaccine (vero cell) against EV71 of (without adjuvant) 640U /0.5ml, two doses, 28 days interval
0/0.5ml placebo
0/0.5ml placebo, two doses, 28 days interval
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
* Had any Grade 3 or Grade 4 adverse reaction within 7 days after 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
6 Months
36 Months
ALL
No
Sponsors
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Bejing Vigoo Biological Co., LTD
INDUSTRY
Jiangsu Province Centers for Disease Control and Prevention
NETWORK
Responsible Party
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Locations
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Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
Countries
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References
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Zhu FC, Liang ZL, Li XL, Ge HM, Meng FY, Mao QY, Zhang YT, Hu YM, Zhang ZY, Li JX, Gao F, Chen QH, Zhu QY, Chu K, Wu X, Yao X, Guo HJ, Chen XQ, Liu P, Dong YY, Li FX, Shen XL, Wang JZ. Immunogenicity and safety of an enterovirus 71 vaccine in healthy Chinese children and infants: a randomised, double-blind, placebo-controlled phase 2 clinical trial. Lancet. 2013 Mar 23;381(9871):1037-45. doi: 10.1016/S0140-6736(12)61764-4.
Other Identifiers
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JSVCT005
Identifier Type: -
Identifier Source: org_study_id