E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The effectiveness of Ambirix will be investigated in 2 groups: 1) children with hiv-infection, with CD4 counts > 15% 2) children with a rheumatic disease for which immune-suppressive medication is used. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002725 |
E.1.2 | Term | Anti-HIV positive |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059176 |
E.1.2 | Term | Juvenile idiopathic arthritis |
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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 |
How effective is combined vaccination against hepatitis A and B in hiv-infected children and in children using immune-suppressive medication for juvenile idiopathic arthritis? |
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E.2.2 | Secondary objectives of the trial |
Is the degree of immunesuppression related/ associated with the response to vaccination? Markers for degree of immunesuppression are: for hiv-infected children: CD4-cell count and viral load for children using immune-suppressive medication for JIA: dosage and duration of use of the immunesuppressive medication. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All children from 1 up to and including 15 years of age, known with: - hiv-infection irrespective of treatment status. The most recent tested CD4 T cell percentage should be 15% or higher (group 1); OR: - juvenile idiopathic arthritis, for which one or more of the following treatments is used (orally or systemically): Prednis(ol)on ≥ 0.25 mg/ kg body weight, or another corticosteroid in equivalent dosage; Etanercept (Enbrel®); Infliximab (Remicade®); Methotrexaat (Emthexate® or Metoject®) (group 2) are eligible for inclusion. |
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E.4 | Principal exclusion criteria |
Not eligible for inclusion are: - children who have received one or more vaccinations against hepatitis A and/ or hepatitis B before; - children who have been infected with hepatitis A and/ or hepatitis B (serologically proven); - children who received immunoglobulins within 6 months prior to study entrance. - children known with a blood clotting disorder which prohibits intramuscular administration of the vaccine. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end points of this study are: - the percentages of children with hiv or use of immunesuppressive medication who seroconverted for hepatitis A (anti-hepatitis A virus IgG antibodies, anti-HAV-IgG) and hepatitis B (anti-hepatitis B surface antigen IgG antibodies, anti-HBs-IgG): 4-6 weeks after the first vaccination, prior to the second vaccination, and 4-6 weeks after the second vaccination. For hepatitis A, seroconversion is defined as: more than 30 IU/L anti-HAV-IgG. For hepatitis B, seroconversion is defined as: more than 10 IU/L anti-HBs IgG. - the geometric mean titre (GMT) per group, at aforementioned time points.
These will be compared with seroconversionpercentages and GMT of non-immune-suppressed children (already known from previously performed studies). |
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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 | No |
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 | No |
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 | No |
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
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |