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The Immunogenicity and Safety of 60mcg/30mcg Recombinant Hepatitis B Vaccines in People Who Failed to Respond to Routine Administration of Hepatitis B Vaccines

NCT01203319 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1091

Last updated 2012-04-27

Study results available
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Summary

This study is an expanded Phase 2/Phase 3 clinical trial base on the safety data obtained from the phase 1 clinical trial. The purpose of this study is to further evaluate the immunogenicity and safety of 60mcg/30mcg recombinant hepatitis B vaccines in people aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines and to explore the optimizing immunizing dose and immune procedure.

Conditions

Interventions

BIOLOGICAL

60mcg/1.0ml recombinant hepatitis B vaccine

to receive 60mcg/1.0ml recombinant HBV vaccines on day 0, 30 and 60

BIOLOGICAL

30mcg/1.0ml recombinant hepatitis B vaccine

to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.

BIOLOGICAL

10mcg/1.0ml recombinant hepatitis B vaccine

to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60

Sponsors & Collaborators

  • Shenzhen Kangtai Biological Products Co., LTD

    collaborator INDUSTRY

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Principal Investigators

  • Feng-Cai Zhu, Master · Jiangsu Provincial Center for Diseases Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-12-31
Completion
2011-03-31

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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 NCT01203319 on ClinicalTrials.gov