Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

Hepatitis B Clinical Trial

Official title:

The Safety and Immunogenicity of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02764671
• Other study ID #: KT0012
• Status: Recruiting
• Phase: Phase 4
• First received: May 4, 2016
• Last updated: May 5, 2016
• Start date: May 2015
• Est. completion date: September 2020

Study information

• Verified date: May 2016
• Source: Shenzhen Kangtai Biological Products Co., LTD
• Contact: Huang Zhuhang, master
• Phone: +86-020-36271871
• Email: jade_lyy[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Hepatitis
• Hepatitis A
• Hepatitis B
• Liver Diseases

Intervention

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.

Locations

Country	Name	City	State
China	Gaozhou District Center for Disease Control and Prevention	Maoming	Guangdong
China	Xinxing District Center for Disease Control and Prevention	Yunfu	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Kangtai Biological Products Co., LTD	Guangdong Provincial Institute of Biological Products And Materia Medica

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events		Within 30 days after hepatitis B vaccination	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No