Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

Shenzhen Kangtai Biological Products

Status and phase

Unknown

Phase 4

Conditions

Hepatitis

Digestive System Diseases

Hepatitis B

Liver Diseases

Treatments

Biological: 10μg/0.5ml recombinant hepatitis B vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02764671

KT0012

Details and patient eligibility

About

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.

Enrollment

5,000 estimated patients

Sex

All

Ages

Under 24 hours old

Volunteers

Accepts Healthy Volunteers

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.