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

• Register: EUCTR
• Last refreshed on: 10 June 2014
• Main ID: EUCTR2009-016911-39-SK
• Date of registration: 15/04/2010
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 05/05/2010
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016911-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Slovakia

Key inclusion & exclusion criteria

Inclusion criteria:
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.
•Female subjects of childbearing potential may be enrolled in the study, if the subject:
?has practiced adequate contraception for 30 days prior to vaccination, and
?has a negative pregnancy test on the day of vaccination, and
?has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.


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:
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.
•Female planning to become pregnant or planning to discontinue contraceptive precautions.
•Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
•Acute disease and/or fever at the time of enrolment.
•Fever is defined as temperature = 37.5°C (99.5°F) on oral, axillary or tympanic setting
?Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.



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

Health Condition(s) or Problem(s) studied

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.

Intervention(s)

Trade Name: Engerix B 10ug
Product Name: Engerix-B
Product Code: JO7BC01
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hepatitis B surface antigen
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, 10-11 years after primary infant vaccination with three doses of Infanrix hexa or Engerix-B at 3, 5 and 11 months of age.
•To evaluate the safety and reactogenicity of a challenge dose of HBV vaccine in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs).

Main Objective: To assess the anti-HBs antibody response to a challenge dose of HBV vaccine in subjects aged 11-12 years, vaccinated in infancy with three doses of Infanrix hexa or Engerix-B at 3, 5 and 11 months of age.

Primary end point(s): •Anti-HBs antibody concentrations one month after a challenge dose of HBV vaccine: Percentage of subjects with anti-HBs antibody concentrations greater than or equal to 100 mIU/ml.

Secondary ID(s)

113954