Clinical trial NCT00697866: Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control
Official title: Evaluating the Consistency of 3 Consecutive Lots of GSK Biologicals' Novel Adjuvanted HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as a Control, Administered According to a 0, 1, 2-month Schedule in Healthy Volunteers (15-50y).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Adjuvanted hepatitis B vaccine
Hepatitis B
Recombinant hepatitis B vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 951
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the present study is to evaluate the immunogenicity and safety of three consecutive production lots of the novel adjuvanted HBV vaccine. The safety of the candidate vaccine will be assessed using Engerix™-B as control.

Detailed description: Double-blind for the identity of the consistency lots, single-blind for the control group/study vaccine identity.

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

Eligibility criteria: Inclusion Criteria:

* A male or female between, and including, 15 and 50 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject/ from the parents or guardians of the subject where applicable
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Planned administration/Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
* Previous vaccination against hepatitis B
* History of non-response to previous hepatitis B vaccination
* Known exposure to hepatitis B within the previous 6 weeks
* History of hepatitis B infection
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* Suspected or confirmed multiple sclerosis in the subject (applicable to Centre 5/France only)
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Hepatomegaly, right upper quadrant abdominal pain or tenderness.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Pregnant or lactating female

Primary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: At month 3
Secondary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: At M1, M2, M3
measure: Anti-RF1 antibody titres in a subset of 50 subjects per group
timeFrame: At months 0 and 3
measure: Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms
timeFrame: During a 4-day follow-up after vaccination
measure: Occurrence, intensity and relationship to vaccination of unsolicited symptoms
timeFrame: Within 30 days after each vaccination
measure: Occurrence, intensity and relationship to vaccination of serious adverse events
timeFrame: During the study period
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: