Immune response after Human Papillomavirus vaccination in patients with auto-immune disease - HPV study

• Conditions: Juvenile Idiopathic ArthritisSystemic lupus erythematosus childhood dermatomyositis; MedDRA version: 9.1Level: LLTClassification code 10042947Term: Systemic lupus erythematosus synd; MedDRA version: 9.1Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritis; MedDRA version: 9.1Level: LLTClassification code 10008521Term: Childhood dermatomyositis

• Registration Number: EUCTR2008-008169-36-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-29
• Last Update Posted: 9 March 2015

Recruitment & Eligibility

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

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
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

- 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.

Study & Design

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