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Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

Primary Purpose

Hepatitis, Hepatitis B, Liver Diseases

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
10μg/0.5ml recombinant hepatitis B vaccine
Sponsored by
Shenzhen Kangtai Biological Products Co., LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis focused on measuring recombinant hepatitis B vaccine, safety, immunogenicity

Eligibility Criteria

undefined - 24 Hours (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Gaozhou District Center for Disease Control and PreventionRecruiting
  • Xinxing District Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

10μg/0.5ml recombinant HBV vaccine

Arm Description

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

Outcomes

Primary Outcome Measures

Number of subjects with adverse events

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 4, 2016
Last Updated
May 5, 2016
Sponsor
Shenzhen Kangtai Biological Products Co., LTD
Collaborators
Guangdong Provincial Institute of Biological Products And Materia Medica
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1. Study Identification

Unique Protocol Identification Number
NCT02764671
Brief Title
Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates
Official Title
The Safety and Immunogenicity of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Kangtai Biological Products Co., LTD
Collaborators
Guangdong Provincial Institute of Biological Products And Materia Medica

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis, Hepatitis B, Liver Diseases, Digestive System Diseases
Keywords
recombinant hepatitis B vaccine, safety, immunogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10μg/0.5ml recombinant HBV vaccine
Arm Type
Experimental
Arm Description
5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60.
Intervention Type
Biological
Intervention Name(s)
10μg/0.5ml recombinant hepatitis B vaccine
Intervention Description
5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60.
Primary Outcome Measure Information:
Title
Number of subjects with adverse events
Time Frame
Within 30 days after hepatitis B vaccination
Secondary Outcome Measure Information:
Title
Geometric mean titer of anti-hepatitis B virus surface antigen antibody
Description
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
Title
Geometric mean titer of anti-hepatitis B virus surface antigen antibody
Description
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
Title
Geometric mean titer of anti-hepatitis B virus surface antigen antibody
Description
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
Title
Geometric mean titer of anti-hepatitis B virus surface antigen antibody
Description
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huang Zhuhang, master
Phone
+86-020-36271871
Email
jade_lyy@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zheng Huizhen, master
Organizational Affiliation
Guangdong Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaozhou District Center for Disease Control and Prevention
City
Maoming
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang Zhuhang, Master
Phone
+86-020-36271871
Email
jade_lyy@126.com
Facility Name
Xinxing District Center for Disease Control and Prevention
City
Yunfu
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang Zhuhang, master
Phone
+86-020-36271871
Email
jade_lyy@126.com

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

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