Four dose vaccination course with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine or with GSK Biologicals’ HBV 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 7 to 9 years of age.
Conditions
Interventions
Product Name: Engerix B Kinder
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: rDNA Hepatitis B surface antigen
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type:
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
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 7 to 9 years at the time of study entry (from and including the 7th birthday until and including the 9th birthday). • Written informed consent obtained from the parent or guardian of the subject. • In addition to the informed consent that will be signed by parents/guardians or legally acceptable representative, informed assent of the subject will be sought for if the subject is judged able to understand (optional). • 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 DTPa-HBV-IPV/Hib vaccine or a total of 4 doses of HBV vaccine (co-administered with DTPa-IPV/Hib vaccine) in the primary studies DTPa-HBV-IPV-039 or DTPa-HBV-IPV-048 and a booster dose of the same vaccines in the booster studies DTPa-HBV-IPV-058 or DTPa-HBV-IPV-059. 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: • 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 or HBV vaccine in the second year of life. • History of or intercurrent Hepatitis B disease. • 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. • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before challenge dose of HBV vaccine and ending 30 days after. • 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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the anti-HBs antibody response to a challenge dose of HBV vaccine in subjects aged 7 to 9 years, previously primed and boosted with 4 doses of Infanrix hexa in the first two years of life.;Secondary Objective: To assess the anti-HBs antibody response to a challenge dose of HBV vaccine in subjects aged 7 to 9 years, previously primed and boosted with 4 doses of Engerix™-B in the first two years of life. To assess the persistence of anti-HBs antibodies at 7 to 9 years in children previously vaccinated with 4 doses of Infanrix™ hexa or 4 doses of Engerix™-B in the first two years of life. To assess the persistence of antibodies to all other vaccine antigens i.e. diphtheria and tetanus toxoids, pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN), poliovirus types 1, 2 and 3 and polyribosyl-ribitol-phosphate (PRP) in both groups at 7-9 years of age. To evaluate the safety and reactogenicity of the challenge dose of HBV vaccine in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs). ;Primary end point(s): One month after challenge dose of HBV vaccine, for subjects previously primed and boosted with 4 doses of Infanrix™ hexa in the first two years of life: • Anti-HBs antibody concentrations >= 100 mIU/ml. | — |
Countries
Germany
Outcome results
None listed