A Study to Evaluate the Immunogenicity and Safety of EV71 Vaccine in Pediatric Subjects
NCT ID: NCT03268083
Last Updated: 2021-10-26
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
140 participants
INTERVENTIONAL
2016-07-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A1
3 to 6 years
EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
Two vaccinations at 28 days apart
Group A2
3 to 6 years
EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
Two vaccinations at 28 days apart
Group A3
3 to 6 years
EV71 vaccine ([1 μg total protein ] per dose)
Two vaccinations at 28 days apart
Group B1
2 to 35 months
EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
Two vaccinations at 28 days apart
Group B2
2 to 35 months
EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
Two vaccinations at 28 days apart
Group B3
2 to 35 months
EV71 vaccine ([1 μg total protein ] per dose)
Two vaccinations at 28 days apart
Interventions
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EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
Two vaccinations at 28 days apart
EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
Two vaccinations at 28 days apart
EV71 vaccine ([1 μg total protein ] per dose)
Two vaccinations at 28 days apart
Eligibility Criteria
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Inclusion Criteria
2. Subject's guardians are able and willing to comply with study procedures and provide the signed informed consent.
3. Subject is able and can comply with the requirements of the protocol.
4. Subject with body temperature ≤38°C.
Exclusion Criteria
2. Subject with a history of herpangina, hand-foot-mouth disease,and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 3 months.
3. Subject with gestation \< 37 weeks.
4. Subject with birth weight \<2.5 kg.
5. Subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
6. Family history of seizures or progressive neurological disease.
7. Family history of congenital or hereditary immunodeficiency.
8. Severe malnutrition or dysgenopathy.
9. Major congenital defects or serious chronic illness, including perinatal brain damage.
10. Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura).
11. Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or blood draws.
12. Any acute infections 7 days prior to administrating the first vaccination.
13. Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during the study period.
14. Administration of any vaccines within 14 days prior to randomization.
15. Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the study period.
16. Chronic administration (defined as \> 14 days) of immunosuppressants or other immunomodulators or systemic corticosteroids within 6 months prior to vaccination or planned use during the study period.
17. Subjects who had ever received investigational EV-71 vaccine prior to randomization.
18. Under anti-tuberculosis prevention or therapy.
19. Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.
2 Months
6 Years
ALL
Yes
Sponsors
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Enimmune Corporation
INDUSTRY
Responsible Party
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Locations
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China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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References
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Hung MC, Cho CY, Chen CJ, Lai CC, Wu KG. Immunogenicity and safety of an inactivated enterovirus A71 vaccine in children 3-6 years and 2-35 months of age- an open-label, randomized phase IIb clinical trial. Vaccine. 2019 Sep 3;37(37):5559-5566. doi: 10.1016/j.vaccine.2019.07.096. Epub 2019 Aug 6.
Other Identifiers
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EV-BR1501
Identifier Type: -
Identifier Source: org_study_id