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

• Register: EUCTR
• Last refreshed on: 11 February 2013
• Main ID: EUCTR2006-000556-41-DE
• Date of registration: 26/09/2006
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 05/12/2006
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000556-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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.

Intervention(s)

Trade Name: Engerix-B Kinder
Product Name: Engerix-B Kinder
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hepatitis B recombinant surface antigen
Current Sponsor code: HBV
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Secondary Objective: To assess the persistence of anti-HBs antibodies in subjects at 4-5 years of age, previously vaccinated with four doses of Infanrix hexa in the first two years of life.
To evaluate the safety of a challenge dose of HBV vaccine (Engerix-B Kinder) in terms of serious adverse events (SAEs) during the study period.

Main Objective: To assess the anti-HBs antibody response to a challenge dose of HBV vaccine (Engerix-B Kinder) in subjects at 4-5 years of age, previously vaccinated with four doses of Infanrix hexa in the first two years of life.

Primary end point(s): One month after the challenge dose of HBV vaccine:
Anti-HBs antibody concentrations >= 100 mIU/ml.

Secondary ID(s)

106789