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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02764671

Enrollment

5000

Registered

2016-05-06

Start date

2015-05-31

Completion date

2020-09-30

Last updated

2016-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System Diseases, Hepatitis, Hepatitis B, Liver Diseases

Keywords

recombinant hepatitis B vaccine, safety, immunogenicity

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.

Interventions

BIOLOGICAL10μg/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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 24 Hours

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Geometric mean titer of anti-hepatitis B virus surface antigen antibody	The 30th day 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.

Countries

China

Contacts

Primary ContactHuang Zhuhang, master

jade_lyy@126.com+86-020-36271871

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026