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Trial record 2 of 349 for:    hepatitis b | Open Studies

Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Shenzhen Kangtai Biological Products Co., LTD
Sponsor:
Collaborator:
Guangdong Provincial Institute of Biological Products And Materia Medica
Information provided by (Responsible Party):
Shenzhen Kangtai Biological Products Co., LTD
ClinicalTrials.gov Identifier:
NCT02764671
First received: May 4, 2016
Last updated: May 5, 2016
Last verified: May 2016
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 24 Hours   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Control and Prevention
  More Information

Responsible Party: Shenzhen Kangtai Biological Products Co., LTD
ClinicalTrials.gov Identifier: NCT02764671     History of Changes
Other Study ID Numbers: KT0012 
Study First Received: May 4, 2016
Last Updated: May 5, 2016
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 02, 2016