Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates
NCT ID: NCT02764671
Last Updated: 2016-05-06
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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UNKNOWN
PHASE4
5000 participants
INTERVENTIONAL
2015-05-31
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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10μg/0.5ml recombinant HBV vaccine
5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60.
10μg/0.5ml recombinant hepatitis B vaccine
5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60.
Interventions
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10μg/0.5ml recombinant hepatitis B vaccine
5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60.
Eligibility Criteria
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Inclusion Criteria
* Subjects with a birth weight ≥ 2500g;
* Subjects' guardians are able to understand and sign informed consent;
* Subjects who can and will comply with the requirements of the protocol.
Exclusion Criteria
* Subjects' birth mother had immune system dysfunction, or history of organ transplantation or blood dialysis;
* Subjects' parents had a medical history of allergic to any ingredient of the vaccine, including supplementary material and formaldehyde;
* Subjects' parents had a medical history of allergic to combined hepatitis A and B vaccine(HAB) or hepatitis B vaccine;
* Subjects had serious acute and chronic diseases;
* with temperature ≧37.1℃;
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.
24 Hours
ALL
Yes
Sponsors
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Guangdong Provincial Institute of Biological Products And Materia Medica
OTHER
Shenzhen Kangtai Biological Products Co., LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Zheng Huizhen, master
Role: PRINCIPAL_INVESTIGATOR
Guangdong Center for Disease Prevention and Control
Locations
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Gaozhou District Center for Disease Control and Prevention
Maoming, Guangdong, China
Xinxing District Center for Disease Control and Prevention
Yunfu, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KT0012
Identifier Type: -
Identifier Source: org_study_id
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