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 4-6 years old, previously vaccinated with 4 doses of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine, in clinical trials conducted by GSK Biologicals. - DTPa-HBV-IPV-111

• Conditions: Four dose vaccination course with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine, given as a three-dose primary vaccination series in the first year of life, followed by a booster in the second year of life: immune persistence and hepatitis B vaccine challenge at 4-6 years of age.

• Registration Number: EUCTR2006-000553-22-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

•Subjects who the investigator believes that their parents/guardians 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 4 to 6 years at the time of study entry (from and including the 4th birthday until and including the 6th birthday).
•Written informed consent obtained from the parent or guardian of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Subjects who have received a total of 4 doses of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine either administered alone or co-administered with a licensed vaccine, as primary vaccination in the first year of life and as booster vaccination in the second year of life in clinical trials conducted by GSK Biologicals.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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).
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the challenge dose of HBV vaccine, or planned use during the study period.
•Evidence of previous hepatitis B booster vaccination since administration of the fourth dose of DTPa-HBV-IPV/Hib vaccine in the second year of life.
•History of or intercurrent Hepatitis B disease.
•Planned administration / administration of a vaccine not foreseen by the study protocol during the period starting from 30 daysbefore and ending 30 days after the challenge dose of HBV vaccine.
•Administration of immunoglobulins and/or any blood products within the three months preceding 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, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).

Study & Design

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