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UNKNOWNPHASE4

Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

The Safety and Immunogenicity of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates

NCT02764671•Shenzhen Kangtai Biological Products Co., LTD

View on ClinicalTrials.gov

Summary

The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects who are healthy full-term infants after birth, Apgar score ≥8;
•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

•Family history of eclampsia, epilepsy and encephalopathy;
•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.

Locations (2)

Gaozhou District Center for Disease Control and Prevention

Maoming, Guangdong, China

Xinxing District Center for Disease Control and Prevention

Yunfu, Guangdong, China

Key Dates

Start Date

May 1, 2015

Primary Completion Date

September 1, 2020

Completion Date

September 1, 2020

Last Updated

May 6, 2016

Enrollment

5,000

ESTIMATED participants

Conditions

HepatitisHepatitis BLiver DiseasesDigestive System Diseases

Interventions

10μg/0.5ml recombinant hepatitis B vaccine

BIOLOGICAL

Contacts

Huang Zhuhang, master

CONTACT

+86-020-36271871 jade_lyy@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

Inclusion Criteria

Exclusion Criteria

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