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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2007-004579-21-NL |
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Date of registration:
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29/08/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus?
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Scientific title:
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Does booster influenza vaccination improve vaccination efficacy in patients with quiescent systemic lupus erythematosus? |
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Date of first enrolment:
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27/08/2007 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004579-21 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: compared to healthy controls
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients
- patients have to fulfil international disease criteria of SLE
- quiescent disease, defined as SLEDAI =5
- informed consent
Healthy controls
- informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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:
Patients
- active disease, defined as SLEDAI >5
- use of prednisone >30 mg/day
- pregnancy
- malignancy
- no informed consent
Healthy controls
- use of immunosuppressives
- malignancy
- pregnancy
- no informed consent
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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systemic lupus erythematosus (SLE)
SLE is a systemic autoimmune disease.
MedDRA version: 9.1
Level: LLT
Classification code 10025139
Term: Lupus erythematosus systemic
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Intervention(s)
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Trade Name: Influvac
Pharmaceutical Form: Injection*
INN or Proposed INN: Influenz virus surface antigens
Other descriptive name: INFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 45-
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Primary Outcome(s)
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Primary end point(s): Seroprotection rate (the percentage of SLE patients with a titre equal to or greater than 40 against all three vaccine strains) in SLE patients after two influenza vaccinations as compared to a single vaccination.
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Secondary Objective:
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Main Objective: To determine whether a second, booster, influenza vaccination leads to a higher seroprotection rate in SLE patients, as compared to a single vaccination.
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Secondary ID(s)
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METc 2007/172
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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