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Clinical Trial of Recombinant Hepatitis B Vaccine (Hansenula Polymorpha, 10μg)

NCT04075201 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2021-07-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immunogenicity of the recombinant hepatitis B vaccine (Hansenula polymorpha, 10μg), with an open-labelled design in adults and randomized, double-blinded, and positive controlled design in children and neonates.

Conditions

Interventions

BIOLOGICAL

Three doses of investigational vaccine

Three doses of investigational hepatitis B vaccine (10μg/0.5ml) developed by Sinovac Research \& Development Co., Ltd. on the schedule of month 0,1,2

BIOLOGICAL

Three doses of control vaccine

Three doses of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc.

BIOLOGICAL

One dose of investigational vaccine

One dose of investigational hepatitis B vaccine (10μg/0.5ml) developed by Sinovac Research \& Development Co., Ltd.

BIOLOGICAL

One dose of control vaccine

One dose of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc.

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Shengli Xia, Doctor · Henan Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-07
Primary Completion
2021-05-30
Completion
2021-07-25

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04075201 on ClinicalTrials.gov