A phase IV, open-label, single-centre study to assess the long-term persistence of hepatitis A antibodies in healthy adults, primed 21 to 25 years earlier with GSK Biologicals’ hepatitis A vaccine Havrix® (SB208109) in studies HAV-112 (208109/108) or HAV-123 (208109/114). - HAV-248

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy volunteers (Vaccination against hepatitis A in healthy adults)
Sponsor: GlaxoSmithKline Biologicals
Status: Active, not recruiting
Last Updated: 10 years ago

No summary available.

Registry

who.int

Start Date

April 25, 2014

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•A male or female who received two doses of Havrix in study HAV\-112 (208109/108\) or HAV\-123 (208109/114\), and received no further booster dose since then.
•Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow\-up visits).
•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 120
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range 0

•History of hepatitis A disease since completion of the primary vaccination series in studies HAV\-112 (208109/108\) or HAV\-123 (208109/114\).
•Administration of a hepatitis A vaccine at any time since completion of the primary vaccination series in studies HAV\-112 (208109/108\) or HAV\-123 (208109/114\) including a challenge dose of the study vaccine, as a part of the study procedures, during the long\-term persistence phase.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
•Administration of hepatitis A immunoglobulins and/or any blood products and/or long\-acting immune\-modifying drugs within six months prior to study entry.
•Chronic administration of immunosuppressants or other immune\-modifying drugs within six months prior to study entry. For corticosteroids, this will mean prednisone \>\=20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
•Administration of long\-acting immune\-modifying drugs within six months prior to study entry (e.g. infliximab).
•Concurrently participating in another clinical study, during the period starting 30 days before and ending 30 days after each study visit, in which the subject has been or will be exposed to an investigational or a non\-investigational vaccine/product.