A phase IV, open-label, multi-centre study to assess the long-term persistence of hepatitis A and B antibodies in healthy adult subjects, primed 16 to 20 years earlier with GSK Biologicals’ combined hepatitis A and B vaccine, Twinrix® (SB208127) in study HAB-084 (208127/084). - HAB-171 EXT 084 Y16-20

GlaxoSmithKline Biologicals s.a.0 sites180 target enrollmentApril 9, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy volunteers (Vaccination against hepatitis A and hepatitis B in healthy adults)
Sponsor: GlaxoSmithKline Biologicals s.a.
Enrollment: 180
Status: Active, not recruiting
Last Updated: 9 years ago

No summary available.

Registry

who.int

Start Date

April 9, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
•A male or female who received two/three doses of Twinrix according to his/her group allocation in study HAB\-084 (208127/084\), and received no further dose of any hepatitis A and/or B vaccine since then.
•Written informed consent obtained from the subject.
•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 180
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune\-modifying drugs within six months prior to study entry. Inhaled and topical steroids are allowed.
•Administration of long\-acting immune\-modifying drugs within six months prior to the study entry.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non\-investigational vaccine/product (pharmaceutical product or device).
•Administration of any hepatitis A and/or B vaccine at any time since completion of the primary vaccination series in HAB\-084 (208127/084\) study, including a challenge dose of the study vaccine, as a part of the study procedures, during the long\-term persistence phase.
•Documented history of hepatitis A or B disease since completion of the primary vaccination series in HAB\-084 (208127/084\) study.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•Administration of immunoglobulins within six months prior to study entry.