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Trial record 5 of 311 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

This study is currently recruiting participants.
Verified May 2016 by Shenzhen Kangtai Biological Products Co., LTD
Sponsor:
ClinicalTrials.gov Identifier:
NCT02764671
First Posted: May 6, 2016
Last Update Posted: May 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Guangdong Provincial Institute of Biological Products And Materia Medica
Information provided by (Responsible Party):
Shenzhen Kangtai Biological Products Co., LTD
  Purpose
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.

Condition Intervention Phase
Hepatitis Hepatitis B Liver Diseases Digestive System Diseases Biological: 10μg/0.5ml recombinant hepatitis B vaccine Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Safety and Immunogenicity of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates

Resource links provided by NLM:


Further study details as provided by Shenzhen Kangtai Biological Products Co., LTD:

Primary Outcome Measures:
  • Number of subjects with adverse events [ Time Frame: Within 30 days after hepatitis B vaccination ]

Secondary Outcome Measures:
  • Geometric mean titer of anti-hepatitis B virus surface antigen antibody [ Time Frame: The 30th day after whole course of hepatitis B vaccination ]
    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 [ Time Frame: The 1th year after whole course of hepatitis B vaccination ]
    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 [ Time Frame: The 2th year after whole course of hepatitis B vaccination ]
    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 [ Time Frame: The 3th year after whole course of hepatitis B vaccination ]
    Geometric mean titer of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.


Estimated Enrollment: 5000
Study Start Date: May 2015
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764671


Contacts
Contact: Huang Zhuhang, master +86-020-36271871 jade_lyy@126.com

Locations
China, Guangdong
Gaozhou District Center for Disease Control and Prevention Recruiting
Maoming, Guangdong, China
Contact: Huang Zhuhang, Master    +86-020-36271871    jade_lyy@126.com   
Xinxing District Center for Disease Control and Prevention Recruiting
Yunfu, Guangdong, China
Contact: Huang Zhuhang, master    +86-020-36271871    jade_lyy@126.com   
Sponsors and Collaborators
Shenzhen Kangtai Biological Products Co., LTD
Guangdong Provincial Institute of Biological Products And Materia Medica
Investigators
Principal Investigator: Zheng Huizhen, master Guangdong Center for Disease Prevention and Control
  More Information

Responsible Party: Shenzhen Kangtai Biological Products Co., LTD
ClinicalTrials.gov Identifier: NCT02764671     History of Changes
Other Study ID Numbers: KT0012
First Submitted: May 4, 2016
First Posted: May 6, 2016
Last Update Posted: May 6, 2016
Last Verified: May 2016

Keywords provided by Shenzhen Kangtai Biological Products Co., LTD:
recombinant hepatitis B vaccine
safety
immunogenicity

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Gastrointestinal Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs