Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).

Study Comparing the Immunogenicity and Reactogenicity of GSK Biologicals' HBV-MPL Vaccine Injected According to a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in a Healthy Adult Population (15-40 Years)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00697216

Enrollment

340

Registered

2008-06-13

Start date

1997-03-31

Completion date

Unknown

Last updated

2008-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

Hepatitis B, Recombinant hepatitis B vaccine, Adjuvanted hepatitis B vaccine

Brief summary

This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with Engerix™-B as control administered at 0, 1, 6 months.

Detailed description

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Interventions

BIOLOGICALHBV-MPL vaccine 208129

2-dose intramuscular injection

BIOLOGICALEngerix™-B

3-dose intramuscular injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Age: between 15 and 40 years old. * Good physical condition as established by clinical examination and history taking at the time of entry. * Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period. * Written informed consent obtained from the subjects aged between 18 and 40 and from the parents/tutor when the subjects are aged between 15 and 17 years.

Exclusion criteria

* Positive titres at screening for anti-HBs antibodies. * Elevated serum liver enzymes. * History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. * Any acute disease at the moment of entry. * Chronic alcohol consumption. * Hepatomegaly, right upper quadrant abdominal pain or tenderness. * Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study. * History of allergic disease likely to be stimulated by any component of the vaccine. * Simultaneous participation in any other clinical trial. * Previous vaccination with a hepatitis B vaccine. * Previous vaccination with an MPL containing vaccine. * Administration of immunoglobulins in the past 6 months and during the whole study period * Simultaneous vaccination one week before and one week after each dose of the study vaccine

Design outcomes

Primary

Measure	Time frame
Anti-HBs antibody concentrations	Month 7

Secondary

Measure	Time frame
Anti-HBs antibody concentrations	At months 1, 2, 6, 7 and 12
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms	4-day follow-up period after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms	31-day follow-up after vaccination
Occurrence and relationship to vaccination of Serious Adverse Events (SAEs)	During the study period

Countries

Belgium, Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026