Clinical trial NCT00698087: Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
Official title: Study to Compare the Safety, Immunogenicity and Reactogenicity of Different Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Hepatitis B
Engerix™-B
Adjuvanted recombinant hepatitis B vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary

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:

* Between 18 and 40 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.
* Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry

Exclusion Criteria:

* Pregnancy or lactation.
* Positive titres for anti hepatitis B antibodies
* Any vaccination against hepatitis B in the past.
* Any previous administration of MPL.
* Elevated serum liver enzymes.
* 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.
* Simultaneous administration of any other vaccine(s).
* Administration of any immunoglobulin during the study period.
* Simultaneous participation in any other clinical trial

Primary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: At M3 and M13
measure: Occurrence of local and general solicited symptoms
timeFrame: 4-day follow-up after vaccination
measure: Occurrence of unsolicited symptoms
timeFrame: 30-day follow-up after vaccination
Secondary outcomes:
measure: SAEs
timeFrame: Throughout the study up to 30 days after last vaccination
measure: Anti-HBs antibody concentrations
timeFrame: Months 2, 3, 6, 9, 12, 13
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References: