A phase IV, single-blinded, randomized, single centre study to demonstrate the non-inferiority of immunogenicity elicited by GSK Biologicals’ hepatitis B vaccine, Engerix-B in multidose presentation to that elicited by Engerix-B in monodose presentation when administered according to 0, 1, 6 months schedule in healthy adults aged equal to or above 18 years. - HBV-308

Phase 1

• Conditions: Vaccination against hepatitis B virus in healthy adults aged equal to or greater than 18 years at the time of first vaccination.

• Registration Number: EUCTR2004-005262-20-BE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-18
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Male or female adult aged greater than or equal to 18 years, who is free from obvious health problems and from whom written informed consent is obtained. If the subject is a female then she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
Previous vaccination against hepatitis B
History of hepatitis B infection
Acute disease at the time of enrolment.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified