Status:
COMPLETED
Immune Response After Human Papillomavirus Vaccination in Patients With Autoimmune Disease
Lead Sponsor:
N.M. Wulffraat
Collaborating Sponsors:
National Institute for Public Health and the Environment (RIVM)
Conditions:
Juvenile Idiopathic Arthritis
Systemic Lupus Erythematosus
Eligibility:
FEMALE
12-18 years
Phase:
PHASE4
Brief Summary
In the Netherlands, the human Papillomavirus (HPV) vaccination will be added to the National Vaccination Program for girls to protect against the development of cervical cancer. The vaccine protects a...
Detailed Description
Study design: prospective observational cohort study. Study population: Females aged 12 - 18 years with one of the autoimmune diseases Juvenile Idiopathic Arthritis (JIA), Systemic Lupus Erythematosu...
Eligibility Criteria
Inclusion
- Females
- Clinical diagnosis of JIA, SLE or JDM
- And who are in the following age groups:
- 12 years (these girls are vaccinated via the National Vaccination Program from September 2009)
- 13-18 years (these girls are vaccinated during a national vaccination campaign from March-May 2009)
- Current co-medication: all co-medication prescribed may be continued
- And in the control group: healthy girls aged 13-17 years (these girls are vaccinated during a national vaccination campaign from March-May 2009)
Exclusion
- No HPV vaccination
- Refusal to allow venous puncture
- Proven or suspected cervical carcinoma
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00815282
Start Date
February 1 2009
End Date
January 1 2015
Last Update
November 13 2017
Active Locations (3)
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1
University Medical center Groningen
Groningen, Netherlands, 9700RB
2
Erasmus Medical Center Rotterdam
Rotterdam, Netherlands, 3000CB
3
UMC Utrecht, department of pediatrics
Utrecht, Netherlands, 3508AB