Immunity induced by Yellow Fever vaccination in the elderly (60 years or OLDer) traveller
| ISRCTN | ISRCTN42180653 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42180653 |
| Protocol serial number | LUMC |
| Sponsor | Leiden University Medical Centre (LUMC) (The Netherlands) |
| Funder | Leiden University Medical Centre (LUMC) (The Netherlands) |
- Submission date
- 05/09/2007
- Registration date
- 05/09/2007
- Last edited
- 07/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A.H.E. Roukens
Scientific
Scientific
Leiden University Medical Centre (LUMC)
PO Box 9600
Leiden
2300 RC
Netherlands
| a.h.e.roukens@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomized active-controlled parallel-group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Immunity induced by Yellow Fever vaccination in the elderly (60 years or OLDer) traveller |
| Study acronym | YFOLD |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Yellow Fever vaccination |
| Intervention | Yellow fever vaccination (only an extra intervention in control group), blood drawing and urine sampling. |
| Intervention type | Biological/Vaccine |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
1. Neutralizing antibodies |
| Key secondary outcome measure(s) |
1. Presence of yellow fever virus proteins in urine samples |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 58 |
| Key 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 |
| Key exclusion criteria | 1. Immune suppression due to disease or medication 2. Pregnancy |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 01/10/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 07/12/2011 | 07/10/2021 | Yes | No |
Editorial Notes
07/10/2021: Publication reference and total final enrolment added.
