Clinical trial NCT00697242: Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults
Official title: Study to Compare the Immunogenicity, Safety and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccines With and Without Adjuvant in Healthy Older Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Hepatitis B
Engerix™-B
Recombinant Hepatitis B vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 362
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: In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects

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:

* Healthy male or female subjects between 50 and 70 years old.
* Written informed consent will have been obtained from the subjects.
* Good physical condition as established by physical examination and history taking at the time of entry

Exclusion Criteria:

* Positive titres for anti hepatitis antibodies
* Any vaccination against hepatitis B in the past.
* Any previous administration of MPL
* Elevated serum liver enzymes at two subsequent determinations 14 days apart.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Axillary temperature \> 37.5°C at the time of injection.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Any treatment with immunosuppressive or immunostimulant therapy.
* Any chronic drug treatment, 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.
* Administration of any other vaccine(s) or any immunoglobulin during the study period.
* Simultaneous participation in any other clinical trial.

Primary outcomes:
measure: Anti-hepatitis B surface antigen (HBs) antibody concentrations
timeFrame: At M2 and M7
Secondary outcomes:
measure: Anti-pre-S1 antibody concentrations
timeFrame: Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation
measure: Anti-HBs antibody concentrations
timeFrame: Screening, Months 1, 2, 3, 6, 7, 8 and 12
measure: Occurrence and intensity of local and general solicited symptoms
timeFrame: 4-day after vaccination
measure: Cell mediated immunity
timeFrame: Month 0, Month 2 and month 7
measure: Occurrence of unsolicited adverse events
timeFrame: 30 days after vaccination
measure: Occurrence of serious adverse events
timeFrame: During the study period and 30 days after last vaccine dose
Other outcomes:
Locations:
city: Wien
country: Austria
facility: GSK Clinical Trials Call Center
city: Gent
country: Belgium
facility: GSK Clinical Trials Call Center
city: Hvidovre
country: Denmark
facility: GSK Clinical Trials Call Center
city: Reykjavik
country: Iceland
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References: