Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

Phase 4

• Conditions: Hepatitis B; Hepatitis; Liver Diseases; Digestive System Diseases
• Interventions: Biological: 10μg/0.5ml recombinant hepatitis B vaccine

• Registration Number: NCT02764671
• Lead Sponsor: Shenzhen Kangtai Biological Products Co., LTD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Status Verified: 2016-05
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-05
• Last Update Submitted: 2016-05-05
• Study First Posted: 2016-05-06
• Last Update Posted: 2016-05-06
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
10μg/0.5ml recombinant HBV vaccine	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.

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	Within 30 days after hepatitis B vaccination

Secondary Outcome Measures

Name	Time	Method
Geometric mean titer of anti-hepatitis B virus surface antigen antibody	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.

Trial Locations

Locations (2)

Gaozhou District Center for Disease Control and Prevention; 🇨🇳 Maoming, Guangdong, China

Xinxing District Center for Disease Control and Prevention; 🇨🇳 Yunfu, Guangdong, China