Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Biological: HBV-MPL vaccine 208129; Biological: Engerix™-B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00696917

208129/031

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1,303 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,303 participants in 4 patient groups

Group A

Active Comparator group

Description:

Three doses according to 0, 1, 6-month schedule

Treatment:

Biological: Engerix™-B

Group B

Experimental group

Description:

Two doses according to 0, 6-month schedule, with a placebo injection at Month 1

Treatment:

Biological: HBV-MPL vaccine 208129

Group C

Experimental group

Description:

Two doses according to 0, 6-month schedule, with a placebo injection at Month 1

Treatment:

Biological: HBV-MPL vaccine 208129

Group D

Experimental group

Description:

Two doses according to 0, 6-month schedule, with a placebo injection at Month 1

Treatment:

Biological: HBV-MPL vaccine 208129