Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults

Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine With That of Engerix™-B When Both Are Injected According to 3 Dose Schedule (0, 1, 6 Months) in an Adult Population Aged Between 50 and 70 Years

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00696891

Enrollment

380

Registered

2008-06-13

Start date

1997-06-30

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

Adjuvanted hepatitis B vaccine, hepatitis B, Engerix™-B

Brief summary

This study is conducted to compare the immunogenicity, reactogenicity and safety of Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population

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

3-dose intramuscular injection

BIOLOGICALEngerix™-B

3-dose intramuscular injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

50 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Age: 50 to 70 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

Exclusion criteria

* Positive at screening for anti-HBV 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 recombinant hepatitis B vaccine. * Previous vaccination with an MPL containing vaccine. * Administration of immunoglobulins in the past 6 months and during the whole study period * Vaccination one week before and one week after each dose of the study vaccine

Design outcomes

Primary

Measure	Time frame
Anti-HBs antibody concentrations	At Month 7

Secondary

Measure	Time frame
Occurrence and intensity of solicited local symptoms	4-day follow-up after vaccination
Occurrence and intensity and relationship to vaccination of solicited general symptoms	4-day follow-up after vaccination
Anti-HBs antibody concentrations	At Months 1, 2, 6, 7 and 12
Occurrence, intensity and causal relationship of unsolicited symptoms	Within 30 days after vaccination
Serious adverse events	Throughout study period
Occurrence and intensity of any symptoms (solicited/ unsolicited).	4-day follow-up after vaccination

Countries

Belgium, Canada, Sweden

Outcome results

None listed

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