An open, phase IV, single-group multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in children at 4-5 years of age, previously primed and boosted in the first two years of life with GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine. - DTPa-HBV-IPV-112

• Conditions: Antibody persistence and hepatitis B vaccine challenge in children at 4-5 years of age, previously primed and boosted with 4 doses of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine in routine vaccination practice in Germany.

• Registration Number: EUCTR2006-000556-41-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-26
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for the follow-up visit) should be enrolled in the study.
A male or female of 4 to 5 years of age (from and including the 4th birthday up to but excluding the 6th birthday) at the time of enrolment.
With documented evidence of previous vaccination with four consecutive doses of Infanrix hexa in Germany: as three primary vaccination doses received by 9 months of age and one booster dose received between 11 and 18 months of age.
Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
Healthy subjects as established by medical history and clinical examination before entering into the study.

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).
Evidence of previous hepatitis B booster vaccination since administration of the fourth dose of Infanrix hexa booster in the second year of life.
History of or intercurrent hepatitis B disease.
Hepatitis B vaccination at birth.
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before booster vaccination and ending 30 days after.
Administration of immunoglobulins and/or any blood products within the three months preceding booster vaccination 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 HBV vaccine challenge.

Study & Design

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