Clinical trial NCT00696891: Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Adjuvanted hepatitis B vaccine, hepatitis B, Engerix™-B
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 380
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: At Month 7
Secondary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: At Months 1, 2, 6, 7 and 12
measure: Occurrence and intensity of solicited local symptoms
timeFrame: 4-day follow-up after vaccination
measure: Occurrence and intensity and relationship to vaccination of solicited general symptoms
timeFrame: 4-day follow-up after vaccination
measure: Occurrence and intensity of any symptoms (solicited/ unsolicited).
timeFrame: 4-day follow-up after vaccination
measure: Occurrence, intensity and causal relationship of unsolicited symptoms
timeFrame: Within 30 days after vaccination
measure: Serious adverse events
timeFrame: Throughout study period
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: GSK Clinical Trials Call Center
city: Toronto
country: Canada
facility: GSK Clinical Trials Call Center
city: Göteborg
country: Sweden
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References: