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ISRCTN
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ISRCTN46326316
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ClinicalTrials.gov identifier
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Public title
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Comparison between immune response to different modes of vaccination: intradermal and subcutaneous yellow fever vaccination
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Intradermal yellow fever vaccination with a reduced dose will induce a sufficient protective immunological response comparable to the response elicited by subcutaneous yellow fever vaccination.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Yellow Fever
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Participants - inclusion criteria
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Healthy volunteers, greater than 18 years (previously and not previously vaccinated with yellow fever vaccine)
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Participants - exclusion criteria
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1. Pregnancy
2. Diabetes mellitus
3. Use of immunomodulating medication, e.g. corticosteroids
4. Cytostatica
5. Use of chloroquine
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Anticipated start date
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15/06/2005
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Anticipated end date
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15/06/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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120
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Interventions
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Subcutaneous of intradermal yellow fever vaccination.
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Primary outcome measure(s)
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1. Protective humoral immune response
2. For first time vaccinees measured 4 and 8 weeks post-vaccination, for revaccinees measured 2 weeks post-vaccination.
3. All sera will be analysed by ELISA, Immunofluorescence and plaque reduction assay.
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Secondary outcome measure(s)
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Adverse events measured for three weeks post-vaccination by keeping a diary, viremia measured 5 days post-vaccination by RT-PCR.
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Sources of funding
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1. Leiden University Medical Centre (LUMC) (The Netherlands) - Department of Infectious Diseases
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18431480
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Contact name
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Dr
A.H.E.
Roukens
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Address
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Leiden University Medical Centre (LUMC)
Albinusdreef 2, C5-P
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City/town
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Leiden
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Zip/Postcode
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2333 ZA
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Country
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Netherlands
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Email
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a.h.e.roukens@lumc.nl
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Sponsor
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Leiden University Medical Centre (LUMC) (Netherlands)
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Address
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Albinusdreef 2
P.O. Box 9600
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City/town
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Leiden
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Zip/Postcode
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2300 RC
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Country
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Netherlands
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Email
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Sponsor website:
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http://www.lumc.nl/
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Date applied
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20/12/2005
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Last edited
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25/04/2008
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Date ISRCTN assigned
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20/12/2005
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