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Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents

NCT00697775 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2008-06-16

No results posted yet for this study

Summary

In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15

Conditions

Interventions

BIOLOGICAL

HBV-MPL vaccine Formulation A

Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection

BIOLOGICAL

HBV-MPL vaccine Formulation B

2-dose intramuscular injection

BIOLOGICAL

Engerix™-B

Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1998-03-31
Primary Completion
1999-05-31

Countries

  • Germany

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 NCT00697775 on ClinicalTrials.gov