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Vaccination Response in immunoCompromised Host 2.


- candidate number1471
- NTR NumberNTR273
- ISRCTNISRCTN15762138
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR8-sep-2005
- Secondary IDsp05.115 
- Public TitleVaccination Response in immunoCompromised Host 2.
- Scientific TitleComparison of antibody response upon influenza vaccination after intradermal versus intramuscular injection in immunocompromized hosts.
- ACRONYMRICH 2
- hypothesisIntradermal vaccination with one fith of the total vacine dose intradermally is just as efficient as intramuscular vaccination with the regular dose.
- Healt Condition(s) or Problem(s) studiedHuman immunodeficiency virus (HIV), Hemodialysis, Bone marrow transplant, Lung transplantation, Immunocompromized patients
- Inclusion criteriaImmunocompromized patients at least 18 years of age.
- Exclusion criteria1. Active infection;
2. Pregnancy;
3. Life expectancy of less than 6 months;
4. Thrombocetopenia;
5. Coumarin therapy;
6. Thinskin with steroids;
7. Known allergies;
8. Influenza vaccination within last 9 months.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 4-okt-2005
- planned closingdate1-apr-2006
- Target number of participants580
- Interventions1. Intradermal vaccination;
2. Intramuscular vaccination.
- Primary outcomeGMT 30 days post vaccination.
- Secondary outcomeProtection rates.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES L.B.S. Gelinck
- CONTACT for SCIENTIFIC QUERIES L.B.S. Gelinck
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Infectious Diseases
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Department of Infectious Diseases
- PublicationsN/A
- Brief summaryIntradermal vs intramuscular influenza vaccination in different groups with cellular immunodeficiencies. Intradermal vaccination might lead to better responses.
- Main changes (audit trail)
- RECORD8-sep-2005 - 11-nov-2008


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