E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Juvenile Idiopathic Arthritis Systemic lupus erythematosus childhood dermatomyositis |
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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 | 10042947 |
E.1.2 | Term | Systemic lupus erythematosus synd |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008521 |
E.1.2 | Term | Childhood dermatomyositis |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study the immunogenicity of humane papillomavirus (HPV) vaccination in patients with immunesystem disorders by measuring antibody levels before and after HPV vaccination. The standard registrated HPV vaccine currently used in the Netherlands National Vaccination Program will be used.
The next objective is to evaluate the safety of the HPV vaccination in the patient population by measuring disease activity . |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to study immune regulatory mechanisms induced by HPV vaccination. It will be evaluated whether HPV vaccination is capable of inducing protective regulatory immune responses, such as an increase of T regulatory cells. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- all subtypes of Juvenile Idiopathic Arthritis (JIA) patients according to ILAR criteria - patients with Systemic lupus erythematosus (SLE) - patients with juvenile dermatomyositis - ages 12 - 17 |
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E.4 | Principal exclusion criteria |
- Refusal to allow venous puncture - Allergic reactions to one of the components of the vaccine. (see regular SPC text) - Acute, severe disease accompanied with fever. In this case, the moment of vaccination will be postponed for 1 month. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) immunogenicity of HPV vaccination, measured by antibody titers prior to and after 7, and 12 months of vaccination
2) Safety of HPV vaccination, according to: disease activity of autoimmune disease defined by internationally validated criteria for JIA (core set criteria), SLE Disease Activity Index (SLEDAI), Childhood Myositis Activity score (CMAS)
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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 | No |
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 | 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 | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 0 |
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 | Yes |
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 | |