E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Four dose vaccination course with GSK Biologicals’ DTPa-HBV-IPV/Hib 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 4-6 years of age. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• To assess the anti-HBs antibody response to a challenge dose of HBV vaccine in subjects aged 4-6 years, previously primed and boosted with 4 doses of Infanrix hexa in the first two years of life. |
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E.2.2 | Secondary objectives of the trial |
• To assess the persistence of anti-HBs antibodies at 4-6 years in children previously vaccinated with 4 doses of Infanrix™ hexa 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) at 4-6 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).
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 4 to 6 years at the time of study entry (from and including the 4th birthday until and including the 6th birthday). • Written informed consent obtained from the parent or guardian of the subject. • 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 GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine either administered alone or co-administered with a licensed vaccine, as primary vaccination in the first year of life and as booster vaccination in the second year of life in clinical trials conducted by GSK Biologicals.
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E.4 | Principal 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 in the second year of life. • History of or intercurrent Hepatitis B disease. • Planned administration / administration of a vaccine not foreseen by the study protocol during the period starting from 30 daysbefore and ending 30 days after the challenge dose of HBV vaccine. • 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. • 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).
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E.5 End points |
E.5.1 | Primary end point(s) |
One month after challenge dose of HBV vaccine: • Anti-HBs antibody concentrations >= 100 mIU/ml.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |