Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

Shenzhen Kangtai Biological Products Co., LTD5,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

5,000

Conditions

Hepatitis Hepatitis B Liver Diseases Digestive System Diseases

Interventions

10μg/0.5ml recombinant hepatitis B vaccineBIOLOGICAL

5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60.

Eligibility

Sex: ALLMax age: 24 HoursHealthy volunteers:

Medical Language ↔ Plain English

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

RECRUITING

Xinxing District Center for Disease Control and Prevention

Yunfu, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Number of subjects with adverse events

Time frame: Within 30 days after hepatitis B vaccination

Secondary Outcomes

Geometric mean titer of anti-hepatitis B virus surface antigen antibody

Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.

Time frame: The 30th day after whole course of hepatitis B vaccination

Geometric mean titer of anti-hepatitis B virus surface antigen antibody

Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.

Time frame: The 1th year after whole course of hepatitis B vaccination

Geometric mean titer of anti-hepatitis B virus surface antigen antibody

Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.

Time frame: The 2th year after whole course of hepatitis B vaccination

Geometric mean titer of anti-hepatitis B virus surface antigen antibody

Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.

Time frame: The 3th year after whole course of hepatitis B vaccination

Central Contacts

Huang Zhuhang, master

CONTACT

+86-020-36271871 jade_lyy@126.com

Data from ClinicalTrials.gov

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