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

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 Overview

• Status: Unknown
• Conditions: Liver Diseases; Digestive System Diseases; Hepatitis B; Hepatitis
• Intervention / Treatment: Biological: 10μg/0.5ml recombinant hepatitis B vaccine

• Study Type: Interventional
• Enrollment (Anticipated): 5000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Huang Zhuhang, master; Phone Number: +86-020-36271871; Email: jade_lyy@126.com

Study Locations

• China
  • Guangdong
    • Maoming, Guangdong, China
      • Recruiting
      • Gaozhou District Center for Disease Control and Prevention
      • Contact: Huang Zhuhang, master; Phone Number: +86-020-36271871; Email: jade_lyy@126.com
    • Yunfu, Guangdong, China
      • Recruiting
      • Xinxing District Center for Disease Control and Prevention
      • Contact: Huang Zhuhang, master; Phone Number: +86-020-36271871; Email: jade_lyy@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with adverse events	Within 30 days after hepatitis B vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	The 3th year after whole course of hepatitis B vaccination

Collaborators and Investigators

• Sponsor: Shenzhen Kangtai Biological Products Co., LTD
• Collaborators: Guangdong Provincial Institute of Biological Products And Materia Medica
• Investigators: Principal Investigator: Zheng Huizhen, Master, Guangdong Center for Disease Prevention and Control

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 5, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Estimate): May 6, 2016
• Last Update Submitted That Met QC Criteria: May 5, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: safety; immunogenicity; recombinant hepatitis B vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Liver Diseases; Hepatitis B; Hepatitis; Hepatitis A; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: KT0012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No