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Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)

NCT01311674 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2024-03-18

Study results available
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Summary

Hepatitis B Virus Antibody Booster Program

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

hepatitis B vaccine

Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL

BIOLOGICAL

hepatitis B vaccine

Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL

Sponsors & Collaborators

  • Emergent BioSolutions

    lead INDUSTRY

Principal Investigators

  • Ronald Brown, MD · Cangene Corporation

  • Gerald Winnan, MD · Cangene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-03-11
Completion
2011-03-11

Countries

  • United States

Study Locations

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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 NCT01311674 on ClinicalTrials.gov