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Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine

NCT00805389 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 713

Last updated 2018-08-20

Study results available
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Summary

The aim of this Observer-blind study is to compare different Adjuvant Systems with the same, well-known antigen (HBsAg) already used in the GSK marketed vaccines against Hepatitis B (Engerix-BTM and FendrixTM), in order to better understand the immune response induced by each of the Adjuvant System.

This Protocol Posting has been updated following Protocol amendment 6, October 2009. The section impacted is Eligibility Criteria

Conditions

Interventions

BIOLOGICAL

Engerix-B™

2 doses intramuscular injections

BIOLOGICAL

Fendrix™

2 doses intramuscular injections

BIOLOGICAL

GSK Biologicals' Hepatitis B vaccines (GSK223192A)

2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group

BIOLOGICAL

HBsAg (Booster injection)

Single dose intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-12-15
Primary Completion
2010-09-29
Completion
2011-07-14

Countries

  • Belgium
  • Germany

Study Locations

More Related Trials

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 NCT00805389 on ClinicalTrials.gov