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Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B

NCT00697840 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2008-06-16

No results posted yet for this study

Summary

The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 0, 6 months

Conditions

Interventions

BIOLOGICAL

Engerix™-B

Intramuscular injection, 2 doses

BIOLOGICAL

HBV-MPL 208129

Intramuscular injection, 2 doses

BIOLOGICAL

Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation

Intramuscular injection, 2 doses; experimental formulation

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
1995-06-30
Primary Completion
1996-01-31
Completion
1996-01-31

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 NCT00697840 on ClinicalTrials.gov