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ISRCTN
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ISRCTN42180653
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ClinicalTrials.gov identifier
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Public title
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Immunity induced by Yellow Fever vaccination in the elderly (60 years or OLDer) traveller
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Scientific title
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Acronym
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YFOLD
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Serial number at source
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LUMC
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Study hypothesis
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The induction of immunity might be slower in older persons than in younger individuals. This could influence the occurrence of adverse events induced by the vaccine.
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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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Multicentre, randomised, active controlled, parallel group 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 vaccination
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Participants - inclusion criteria
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Elderly group:
1. Age of 60 years or older
2. Indication for yellow fever vaccination according to Dutch travel guidelines
Control group: age under 60 years
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Participants - exclusion criteria
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1. Immune suppression due to disease or medication
2. Pregnancy
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Anticipated start date
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01/10/2007
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Anticipated end date
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01/10/2008
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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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60
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Interventions
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Yellow fever vaccination (only an extra intervention in control group), blood drawing and urine sampling.
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Primary outcome measure(s)
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1. Neutralizing antibodies
2. Yellow fever viremia
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Secondary outcome measure(s)
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1. Presence of yellow fever virus proteins in urine samples
2. Adverse events
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Sources of funding
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Leiden University Medical Centre (LUMC) (The Netherlands)
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Trial website
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Publications
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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)
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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a.h.e.roukens@lumc.nl
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Sponsor
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Leiden University Medical Centre (LUMC) (The Netherlands)
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Address
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Department of Infectious Diseases
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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Tel
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+31 (0)71 526 9111
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Fax
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+31 (0)71 524 8111
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Email
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a.h.e.roukens@lumc.nl
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Sponsor website:
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http://www.lumc.nl/english/start_english.html
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Date applied
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05/09/2007
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Last edited
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05/09/2007
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Date ISRCTN assigned
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05/09/2007
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