Clinical trial NCT00696917: Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y
Official title: Safety and Immunogenicity of 3 Lots of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine, Administered According to a 2 Dose Schedule, and Engerix™-B Administered According to a 3 Dose Schedule to Healthy Volunteers ≥ 15 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Hepatitis B
Adjuvanted Hepatitis B vaccine
Recombinant Hepatitis B vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 1303
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B.

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:

* A male or female aged ≥ 15 years at the time of the first vaccination. In Centre 103 (Germany) and Centre 1 (Netherlands), only subjects ≥ 18 years will be enrolled.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Written informed consent obtained from the subject and/or from the parent or guardian of the subject.
* If the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine (s) during the study period or within 30 days preceding the first dose of study vaccine.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
* Previous vaccination against hepatitis B.
* History of non-response to previous hepatitis B vaccination.
* Known exposure to hepatitis B within the past 6 weeks.
* History of hepatitis B infection.
* Confirmed human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrollment.
* 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/ administration during the study period.
* Pregnant or lactating female

Primary outcomes:
measure: Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms
timeFrame: Full course of vaccination
measure: Incidence of serious adverse events
timeFrame: Study period
measure: Anti-HBs antibody concentrations
timeFrame: At Month 7
Secondary outcomes:
measure: Occurrence and intensity of solicited local signs and symptoms
timeFrame: 4-day after vaccination
measure: Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms
timeFrame: 4-day after vaccination
measure: Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms
timeFrame: 30 days after vaccination
measure: Occurrence and relationship to vaccination of SAEs
timeFrame: During the study period
measure: Anti-HBs antibody concentrations
timeFrame: At Months 1, 2, 6 and 7
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: GSK Clinical Trials Call Center
state: Victoria
city: Hradec Kralové
country: Czech Republic
facility: GSK Clinical Trials Call Center
city: München
country: Germany
facility: GSK Clinical Trials Call Center
city: Bari
country: Italy
facility: GSK Clinical Trials Call Center
city: Utrecht
country: Netherlands
facility: GSK Clinical Trials Call Center
city: Lausanne
country: Switzerland
facility: GSK Clinical Trials Call Center
city: London
country: United Kingdom
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References: