Response to hepatitis A and B vaccine among children with immunesuppression due to either hiv or immunesuppressive medication - Ambirixresponse immunesuppressed childre

• Conditions: 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.; MedDRA version: 9.1Level: LLTClassification code 10002725Term: Anti-HIV positive; MedDRA version: 9.1Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritis

• Registration Number: EUCTR2008-003280-40-NL
• Lead Sponsor: Public Health Service Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-23
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.
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
;
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.
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

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.
;
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified