Antibody persistence and hepatitis B vaccine challenge in children aged 7–8 years, previously primed and boosted with 4 doses of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) as part of routine vaccination practice in Germany. MedDRA version: 12.1 Level: LLT Classification code 10019731 Term: Hepatitis B
Conditions
Interventions
Trade Name: Engerix-B Kinder
Product Name: Engerix-B Kinder
Pharmaceutical Form: Suspension for injection
Other descriptive name: Hepatitis B (recombinant)
Concentration unit: µg/ml microgram(s)/milli
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for the follow-up visit). •A male or female 7 to 8 years of age (from and including the 7th birthday up to, but excluding the 9th birthday) at the time of enrolment. •Subjects with documented evidence of previous vaccination with four consecutive doses of Infanrix hexa as part of routine vaccination in Germany: three doses of primary vaccination 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/LAR(s) of the subject at the time of enrolment. •In addition to the informed consent that will be signed by the parent(s)/LAR(s), written informed assent of the subject will be sought when the subject is judged able to understand by the investigator (optional). •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
Exclusion criteria: •Child in care. •Use of any investigational or non-registered product (drug or vaccine), other than the study vaccine, within 30 days preceding the dose of study vaccine, or planned use during the study period. •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 and ending 30 days after the HBV challenge dose. •Administration of immunoglobulins and/or any blood products within the three months preceding challenge dose or planned administration during the study period. •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of HBV vaccine. For corticosteroids, prednisone < 0.5 mg/kg/day, inhaled and topical steroids are allowed. •History of any reaction or hypersensitivity likely to be exacerbated by any component of the HBV vaccine, or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). •Acute disease and/or fever at the time of enrolment. - Fever is defined as temperature = 37.5°C on oral, axillary or tympanic setting, or = 38.0 C on rectal setting. The preferred route for recording temperature in this study will be axillary. - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection), without fever, may be enrolled and vaccinated at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess the anti-HBs antibody response to a challenge dose of HBV vaccine (Engerix-B Kinder) in subjects 7–8 years of age, previously vaccinated with four doses of Infanrix hexa in the first two years of life.;Secondary Objective: •To assess the persistence of anti-HBs antibodies in subjects 7–8 years of age, previously vaccinated with four doses of Infanrix hexa in the first two years of life. •To evaluate the safety and reactogenicity of a challenge dose of HBV vaccine (Engerix-B Kinder) in terms of solicited symptoms (local and general), unsolicited symptoms and serious adverse events during the study period. ;Primary end point(s): •Immunogenicity with respect to components of the study vaccine. - Subjects with anti-HBs antibody concentrations = 100 mIU/mL, one month after the challenge dose of HBV vaccine. | — |
Countries
Germany
Outcome results
None listed