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Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Pre-liver Transplant Patients 18 Years of Age

NCT00697554 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2016-09-09

No results posted yet for this study

Summary

The purpose of this study is to enroll pre-liver transplant patients who will be vaccinated with either the novel adjuvanted HBV vaccine or double doses of Engerix™-B. The immunogenicity and safety of the novel adjuvanted vaccine will be compared to Engerix™-B as the control vaccine

Conditions

Interventions

BIOLOGICAL

HBV-MPL vaccine 208129

2-dose primary vaccination followed by 1 booster vaccination by intramuscular injection

BIOLOGICAL

Engerix™-B

3-dose primary vaccination followed by 1 booster vaccination by intramuscular injection of double doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31
Primary Completion
2002-05-31

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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 NCT00697554 on ClinicalTrials.gov