Condition category
Infections and Infestations
Date applied
05/09/2007
Date assigned
05/09/2007
Last edited
05/09/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.lumc.nl/english/start_english.html

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

Publication citations

Additional files

Editorial Notes