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Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B

NCT00698087 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2008-06-16

No results posted yet for this study

Summary

The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary

Conditions

Interventions

BIOLOGICAL

MPL-Adjuvanted recombinant hepatitis B vaccine

Intramuscular injection, 2 or 3 doses, 2 different formulations

BIOLOGICAL

Engerix™-B

Intramuscular injection, 2 or 3 doses

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1995-01-31
Primary Completion
1996-02-29
Completion
1996-02-29

Countries

  • Austria

Study Locations

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Entities

Diseases
Companies

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 NCT00698087 on ClinicalTrials.gov