An open, phase IV, multicentre, study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in healthy children aged 11-12 years, previously vaccinated with GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) or GSK Biologicals’ DTPa-IPV/Hib and HBV (Engerix™- B) vaccines at the ages of 3, 5 and 11 months in clinical trial DTPa-HBV-IPV-031 (217744/031). - DTPa-HBV-IPV-126 BST:031

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Antibody persistence and hepatitis B vaccine challenge at 11-12 years of age (excluding 13th birthday), after primary vaccination with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) or GSK Biologicals’ HBV vaccine (Engerix-B) given at the ages of 3, 5 and 11 months.
Sponsor: GlaxoSmithKline Biologicals
Status: Active, not recruiting
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

April 15, 2010

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•All subjects must satisfy ALL the following criteria at study entry:
•Subjects who the investigator believes that their parents/LAR(s) can and will comply with the requirements of the protocol (return for follow\-up visits) should be enrolled in the study.
•A male or female aged 11\-12 years at the time of study entry (from and including the 11th birthday until and excluding the 13th birthday).
•Written informed consent obtained from the parent or LAR of the subject.
•Study procedures will be explained to subjects and depending on their understanding, optional informed assent will be sought at the discretion of the investigator.
•Written informed assent obtained from the subject (the study purpose and procedures will be explained to the subject by appropriately trained personnel) in addition to the informed consent signed by the parent(s)/LAR(s).
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Subjects who have received all three doses of Infanrix hexa or Engerix\-B in the primary study DTPa\-HBV\-IPV\-031\.
•Female subjects of non\-childbearing potential may be enrolled in the study.
•?Non\-childbearing potential is defined as pre\-menarche, current tubal ligation, hysterectomy, ovariectomy or post\-menopause.

•The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
•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 product (pharmaceutical product or device).
•Child in care.
•Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the challenge dose of HBV vaccine, or planned use during the study period.
•Receipt of hepatitis B (containing) vaccine after vaccination in the primary study DTPa\-HBV\-IPV\-031\.
•History of hepatitis B disease.
•Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the HBV vaccine challenge dose.
•Administration of immunoglobulins and/or any blood products within the three months preceding the challenge dose of HBV vaccine or planned administration 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 challenge dose of HBV vaccine. For corticosteroids, this will mean prednisone \<20 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Pregnant or lactating female.