Contact information
Type
Scientific
Primary contact
Dr A.H.E. Roukens
ORCID ID
Contact details
Leiden University Medical Centre (LUMC)
P.O. Box 9600
Leiden
2300 RC
Netherlands
a.h.e.roukens@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LUMC
Study information
Scientific title
Acronym
YFOLD
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Multicentre, randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Yellow Fever vaccination
Intervention
Yellow fever vaccination (only an extra intervention in control group), blood drawing and urine sampling.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Neutralizing antibodies
2. Yellow fever viremia
Secondary outcome measures
1. Presence of yellow fever virus proteins in urine samples
2. Adverse events
Overall trial start date
01/10/2007
Overall trial end date
01/10/2008
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Immune suppression due to disease or medication
2. Pregnancy
Recruitment start date
01/10/2007
Recruitment end date
01/10/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (The Netherlands)
Sponsor details
Department of Infectious Diseases
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 9111
a.h.e.roukens@lumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leiden University Medical Centre (LUMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary